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`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
`
`02/20/2024
`
`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`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Lj Claim(s)__ is/are rejected.
`() Claim(s)
`is/are objected to.
`Claim(s) 1-35 are subject to 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://www.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)0) The drawing(s) filedon__ is/are: a)(J 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)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) 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)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`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 20240209
`
`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 2 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 12/19/2022.
`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
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application is being examined underthe pre-AlAfirst to invent
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`provisions.
`
`Election/Restrictions
`
`Restriction to one of the following inventions is required under 35 U.S.C. 121:
`
`I.
`
`Claims 1-30 and 34-35, drawn to a modified PH20 polypeptide comprising
`
`one or more amino acid substitutions or modifications and pharmaceutical
`
`composition comprising said polypeptide, classified in CPC C12N 9/2474.
`
`I.
`
`Claims 31-33, drawn to a method of treating hyaluronan-associated
`
`conditions or diseases, including inflammatory disease, tumor, or cancer, with a
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`PH20 polypeptide and therapeutic agent, classified GO1N 2333/914.
`
`Inventions | and Il are related as product and processof use. The inventions
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`can be shownto bedistinct if either or both of the following can be shown: (1) the
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`process for using the product as claimed can be practiced with another materially
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`different product or (2) the product as claimed can be usedin a materially different
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`processof using that product. See MPEP § 806.05(h). In the instant case the
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`polypeptide of invention | can be used in a material different process apart from
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`invention II, such as raising polyclonal antibodies in mice for diagnostic or laboratory
`
`use.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 3
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`Restriction for examination purposesasindicated is proper becauseall the
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`inventions listed in this action are independentor distinct for the reasons given
`
`above and there would be a serious search and/or examination burden if
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`restriction were not required because one or moreof the following reasons apply:
`
`a.
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`the inventions have acquired a separate status in the art in view of their
`
`different classification;
`
`b.
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`the inventions have acquired a separate status in the art due to their
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`recognized divergent subject matter;
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`C.
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`the inventions require a different field of search (for example, searching
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`different classes/subclasses or electronic resources, or employing different search
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`queries);
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`d.
`
`e.
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`another invention;
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`the prior art applicable to one invention would notlikely be applicable to the
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`inventions arelikely to raise different non-prior art issues under 35 U.S.C. 101
`
`and/or 35 U.S.C. 112, first paragraph.
`
`Each group is under a unique CPC class and will require a separate and
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`distinct keyword search, where group | is classified under CPC C12N 9/2474 and
`
`group Il is classified under GO1N 2333/914.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 4
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`Applicant is advised that the reply to this requirement to be complete
`
`must include (i) an election of an invention to be examined even though the
`
`requirement maybe traversed (37 CFR 1.1483) and(ii) identification of the claims
`
`encompassing the elected invention.
`
`The election of an invention may be made with or without traverse. To
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`reserve a right to petition, the election must be madewith traverse. If the reply
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`does not distinctly and specifically point out supposederrors in the restriction
`
`requirement, the election shall be treated as an election without traverse.
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`Traversal must be presentedat the time of election in order to be considered
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`timely. Failure to timely traverse the requirementwill result in the loss of right to
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`petition under 37 CFR 1.144. If claims are added after the election, applicant
`
`must indicate which of these claims are readable upon the elected invention.
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`Should applicant traverse on the ground that the inventions are not
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`patentably distinct, applicant should submit evidenceor identify such evidence
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`now of record showing the inventions to be obvious variants or clearly admit on
`
`the record thatthis is the case. In either instance, if the examiner finds one of the
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`inventions unpatentable over the prior art, the evidence or admission may be
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`used in a rejection under 35 U.S.C. 103 or pre-AlA 35 U.S.C. 103(a) of the other
`
`invention.
`
`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 5
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`The examiner has required restriction between product or apparatus claims
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`and process claims. Where applicant elects claims directed to the
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`product/apparatus, and all product/apparatus claims are subsequently found
`
`allowable, withdrawn processclaims thatincludeall the limitations of the
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`allowable product/apparatus claims should be considered for rejoinder. All
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`claims directed to a nonelected process invention must include all the limitations
`
`of an allowable product/apparatus claim for that process invention to be
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`rejoined.
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`In the event of rejoinder, the requirementfor restriction between the
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`product/apparatus claims and the rejoined processclaims will be withdrawn, and
`
`the rejoined processclaims will be fully examined for patentability in accordance
`
`with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meetall
`
`criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103
`
`and 112.
`
`Until all claims to the elected product/apparatus are found allowable, an
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`otherwise proper restriction requirement between product/apparatus claims and
`
`process claims may be maintained. Withdrawn process claims that are not
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`commensurate in scope with an allowable product/apparatus claim will not be
`
`rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur,
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`

`

`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 6
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`applicant is advised that the process claims should be amended during
`
`prosecution to require the limitations of the product/apparatus claims. Failure to
`
`do so mayresult in no rejoinder. Further, note that the prohibition against double
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`patenting rejections of 35 U.S.C. 121 does not apply wherethe restriction
`
`requirement is withdrawn by the examiner before the patent issues. See MPEP §
`
`804.01.
`
`Any inquiry concerning this communication or earlier communications from
`
`the examiner should be directed to CIARA A MCKNIGHT whosetelephone number
`
`is (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-based collaboration 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 number for 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 Center is available to
`
`registered users. To file and manage patent submissions in Patent Center,visit:
`
`

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`Application/Control Number: 18/068,418
`Art Unit: 1656
`
`Page 7
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`https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-
`
`center for more information about Patent Center and
`
`https://www.uspto.gov/patents/docx for information about filing in DOCX format.
`
`For additional questions, contact the Electronic Business Center (EBC) at 866-21 7-
`
`9197 (toll-free). If you would like assistance from a USPTO Customer Service
`
`Representative, call 800-786-9199 (INUSA OR CANADA)or 571-272-1000.
`
`/CIARA A MCKNIGHT/
`
`Examiner, Art Unit 1656
`
`/SUZANNE M NOAKES/
`Primary Examiner, Art Unit 1656
`
`