www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`18/068,418
`
`12/19/2022
`
`Ge Wei
`
`063995-01-5105-US10
`
`5769
`
`Morgan, Lewis & Bockius LLP (PH)
`2222 MarketStreet
`Philadelphia, PA 19103
`
`MCKNIGHT,CIARA A
`
`ART UNIT
`
`1656
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/01/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`judith.troilo@ morganlewis.com
`phpatentcorrespondence @ morganlewis.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-35 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 31-33 is/are withdrawn from consideration.
`[] Claim(s)__ is/are allowed.
`Claim(s) 1-30 and 34-35 is/are rejected.
`[) Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)( The specification is objected to by the Examiner.
`11)M The drawing(s) filed on 12/19/2022 is/are: a)¥) accepted or b)() objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)2) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a) All
`1.1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) [[] Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240419
`
`Application No.
`Applicant(s)
`18/068,418
`Wei etal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`CIARA A MCKNIGHT
`1656
`No
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 03/05/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`Status of the Application
`
`1.
`
`Claims 1-35 are pending and subject to examination on the merits. Claims 31-33 are
`
`withdrawn from consideration as being drawn to non-elected subject matter.
`
`Election/Restrictions
`
`2.
`
`Applicant's election with traverse of Group I, claims 1-30 and 34-35, in the reply filed on
`
`05 March 2024 is acknowledged. There seems to be an inadvertent mistake with the withdrawal
`
`of 34, where elected Group | includes claim 34 in the previous office action. The examinerwill
`
`treat said claim as being under examination despite the status identifier indicating otherwise.
`
`Please updatethe status identifier in the next response.
`
`The traversal is on the ground(s) that a rejoinder would be requiredif the product claims
`
`were found allowable, since the withdrawn claims are drawn to a process of using said product.
`
`Should the product claims become allowable, a rejoinder of the process claims will be
`
`considered. The requirementis still deemed proper and is therefore made FINAL.
`
`3.
`
`This application ultimately derives benefit to US Provisional 61/631,313 filed 12/30/2011.
`
`Priority
`
`Information Disclosure Statement
`
`4.
`
`The information disclosure statements (IDS) submitted on 16 March 2023 have been
`
`considered by the examiner. Seeinitialed and signed PTO/SB/08’s.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 3
`
`Objections
`
`5.
`
`Claims 1 (lines 3, 5, 9, and 14), 2, 8, 9, 10, 17, 22, and 29 are objected to becauseof the
`
`following informalities: “selected from among” should be changed to a proper Markush term,
`
`“selected from the group consisting of,” to maintain consistency with the previously allowed
`
`parent patents. Appropriate correction is required.
`
`6.
`
`Claims 7 is objected to because ofthe following informalities: in claim 7, “Nor” should be
`
`changed to “N or.” Appropriate correction is required.
`
`7.
`
`Claim 15 is objected to because of the following informalities: “set forth in any of’ should
`
`be changed to a proper Markush term, “selected from the group consisting of,” to maintain
`
`consistency with the previously allowed parent patents. Appropriate correction is required.
`
`Claim Rejections - 35 USC § 112(b)
`
`8.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`9.
`
`Claims 17 and 34-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-
`
`AIA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor (or for
`
`applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards as the invention.
`
`10.
`
`The term "modifications" in claim 17 is a relative term which renders the claim
`
`indefinite. It is unclear if "modifications" here holds the same definition as "modification"
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 4
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`in claim 1, where "modification" refers to "a modification at a position ..." Here in claim
`
`17, however, it appears to be defined as any of the posttranslational modifications listed
`
`afterwards. For examining purposes, the term "modification" is interpreted as referring to
`
`the possible posttranslational modifications of the modified PH20 of claim 1.
`
`It is
`
`recommendedto change "modifications" to "posttranslational modifications" for
`
`increasedclarity.
`
`11.
`
`The term “is modified” in claim 34 renders the claim indefinite. Claim 1 already
`
`recites a “modified PH20;” therefore, “is modified” should be changedto “is further
`
`modified” to increaseclarity to mitigate any confusion between the usage of the similar
`
`terms.
`
`12.
`
`The term “Fe domain’in claim 35 renders the claim indefinite. It is unclear what a
`
`“Fe domain’is, as it is not well-known in the art or defined in the specification. If “Fe” is a
`
`typographical error for “Fc domain’, then it should be changed to “Fc domain,” whichis
`
`well-knownin the art and cited in the specification as a multimerization domain on p. 37
`
`at line 7.
`
`Claim Rejections - 35 USC § 112(d)
`
`13.
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.—Subjectto subsection (e), a claim in dependent
`form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependentform shall be construed to
`incorporate by referenceall the limitations of the claim to which it refers.
`
`The following is a quotation of pre-AlA 35 U.S.C. 112, fourth paragraph:
`
`Subject to the following paragraph[i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim
`in dependent form shall contain a reference to a claim previously set forth and then specify a
`further limitation of the subject matter claimed. A claim in dependent form shall be construed
`to incorporate by referenceall the limitations of the claim to whichit refers.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 5
`
`14.
`
`Claims 8 and 15 rejected under 35 U.S.C. 112(d) or pre-AlA 35 U.S.C. 112, 4th
`
`paragraph, as being of improper dependentform for failing to further limit the subject matter of
`
`the claim upon which it depends, or for failing to include all the limitations of the claim upon
`
`which it depends. Claim 1 recites that the unmodified PH20 polypeptide consists of the amino
`
`acid sequence of SEQ ID NOs: 3, 7, and 32-66, whereas claim 8 recites that the unmodified
`
`polypeptide comprises SEQ ID NOs: 3 and 32-66. Since “comprises” is broader than
`
`“consisting of,” claim 8 does notfurtherlimit claim 1. Regarding claim 15, the recitation of
`
`comprises SEQ ID NOs: 3, 32-66, 623, and 624 makes these claims broaderthan claim 1, and
`
`therefore, not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the
`
`claim(s) in proper dependentform, rewrite the claim(s) in independent form, or present a
`
`sufficient showing that the dependent claim(s) complies with the statutory requirements.
`
`Double Patenting
`
`15.
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`groundedin public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`impropertimewise extension of the “right to exclude” granted by a patent and to prevent
`
`possible harassmentby multiple assignees. A nonstatutory double patenting rejection is
`
`appropriate wherethe conflicting claims are not identical, but at least one examined application
`
`claim is not patentably distinct from the reference claim(s) because the examined application
`
`claim is either anticipated by, or would have been obvious over, the reference claim(s). See,
`
`e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d
`
`1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d
`
`438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA
`
`1969).
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 6
`
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be
`
`used to overcome an actual or provisional rejection based on nonstatutory double patenting
`
`provided the reference application or patent either is shown to be commonly owned with the
`
`examined application, or claims an invention made asa result of activities undertaken within the
`
`scope of a joint research agreement. See MPEP § 717.02 for applications subject to
`
`examination underthe first inventor to file provisions of the AIA as explained in MPEP § 2159.
`
`See MPEP § 2146 et seq.for applications not subject to examination underthe first inventor to
`
`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
`
`The filing of a terminal disclaimer byitself is not a complete reply to a nonstatutory
`
`double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
`
`accompanied by a reply requesting reconsideration of the prior Office action. Even where the
`
`NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection |.B.1.
`
`For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action,
`
`see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c)
`
`maybefiled after final for consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTOInternet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The actualfiling date of the application in
`
`whichthe form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or
`
`PTO/AIA/26) should be used. A web-based eTerminal Disclaimer maybefilled out completely
`
`online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-
`
`processed and approved immediately upon submission. For more information about eTerminal
`
`Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
`
`16.
`
`Claims 1-30 and 34-35 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable overclaims 1, 2, 4, 6-8, 10, 12-13, 19, 23, and 27 of U.S. Patent No.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 7
`
`10865400. Although the claims at issue are notidentical, they are not patentably distinct from
`
`each other because the claims in ‘400 would anticipate the instant claims.
`
`The instant claims in their broadest are drawn to a modified PH20 polypeptide with one
`
`or more amino acid modifications at position 324 (claim 1) with some sequenceidentity to the
`
`PH20 polypeptide encoded in SEQ ID NOs: 3, 7, and 32-66 (claim 2). Additionally, dependent
`
`claims 3 and 5 recite increased resistance or stability and solubility. Claim 4 recites increased
`
`hyaluronidaseactivity. Dependent claims 6-16, 22-23, and 25-26 recite variation modifications
`
`to amino acid 324 in reference to SEQ ID NOs: 3 and 32-66. Dependent claims 17-19 recite an
`
`additional modification of PH20, where the modification can be N-linked glycosylation.
`
`Dependent claims 20-21 recite conjugation to a polymer. Dependentclaims 24 and 27-30 recite
`
`the modified PH20 polypeptide comprising a pharmaceutical composition.
`
`The claims in the ‘400 patentin their broadest are drawn to a modified PH20 polypeptide
`
`with an amino acid replacement at a numberof positions, including 324, resulting in an increase
`
`in hyaluronidase activity compared to an unmodified PH20 polypeptide, where the reference
`
`PH20is selected from SEQ ID NOs: 3, 7, 32-66 (claims 1, 2, 4, 6 and 13).
`
`Dependent claims 7-8 recite additional modifications, such as N-linked glycosylation.
`
`Dependent claim 10 and 12 recite polymer conjugation. Dependentclaims 19 and 23 recite a
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`pharmaceutical composition comprising the modified PH20 polypeptide. Dependent claim 27
`
`recites that the modified PH20is soluble.
`
`It is noted that the reference sequences, SEQ ID NOs: 3, 7, and 32-66are identical
`
`betweenthe two claim sets. Thus, the difference between the claims in the ‘400 claim set
`
`specifies a modified PH20 at a variety of different amino acids. This, however, will still anticipate
`
`the instant claims because position 324 can be selected from the amino acids to be modified.
`
`17.
`
`Claims 1-30 and 34-35 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-3, 5-10, and 14-18 of copending Application No. 18/340,786.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 8
`
`Although the claims at issue are notidentical, they are not patentably distinct from each other
`
`becausethe claims in ‘786 would anticipate the instant claims.
`
`The instant claims in their broadest are drawn to a modified PH20 polypeptide with one
`
`or more amino acid modifications at position 324 with some sequenceidentity to the PH20
`
`polypeptide encoded in SEQ ID NOs: 3, 7, and 32-66 (claims 1, 2, 7-15, 22-23, and 25-26).
`
`Additionally, dependentclaim 4 recite increased hyaluronidaseactivity. Dependent claims 5 and
`
`16 recite that the modified PH20 is soluble. Claim 6 recites that the amino acid replacementat
`
`324 of PH20 is specifically D. Dependent claims 17-19 recite an additional modification of PH20,
`
`where the modification can be N-linked glycosylation. Dependent claims 24 and 27-30 recite the
`
`modified PH20 polypeptide comprising a pharmaceutical composition.
`
`The claims in the ‘786 application in their broadest are drawn to a modified PH20
`
`polypeptide with an amino acid replacementof N, R, or D at position 324 in SEQ ID NO: 3, and
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`the mutant PH20 has some sequenceidentity to SEQ ID NO: 35 (claims 1-4), and the PH20
`
`polypeptide is soluble (claim 7). Dependent claims 5-6 recite increased hyaluronidaseactivity.
`
`Dependent claims 8-10 recite additional modifications, such as N-linked glycosylation.
`
`Dependent claims 14-18 recite a pharmaceutical composition comprising the modified PH20
`
`polypeptide.
`
`It is noted that the reference sequences, SEQ ID NOs: 3 and 35 are identical between
`
`the two claim sets. Thus, the difference between the claims in the ‘786 claim set specifies a
`
`modified PH20 with reference polypeptide SEQ ID NO: 35, specifically. However, since the
`
`instant claim set recites the reference sequences, SEQ ID NOs: 3, 7, and 32-66, SEQ ID NO:
`
`35 is included in the reference sequencechoices.
`
`All claims are rejected. Additionally, claims 1, 7, and 15 are objected to.
`
`Conclusion
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 9
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`Anyinquiry concerning this communication or earlier communications from the examiner
`
`should be directed to CIARA A MCKNIGHT whosetelephone numberis (703)756-4791. The
`
`examiner can normally be reached M-F 8:00am-4:30pm.
`
`Examiner interviews are available via telephone, in-person, and video conferencing
`
`using a USPTO supplied web-basedcollaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO Automated Interview Request(AIR) at
`
`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone numberfor the
`
`organization wherethis application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris available
`
`to registered users. To file and manage patent submissions in Patent Center, visit:
`
`https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent-center for more
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`information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about
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`filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC)at
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`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/CIARA A MCKNIGHT/
`Examiner, Art Unit 1656
`
`/SUZANNE M NOAKES/
`Primary Examiner, Art Unit 1656
`
`