U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
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`REMARKS
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`Please reconsider the application in View of the amendments presented herein and the
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`following remarks.
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`Disposition of the Claims
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`Claims 1-17 are pending. Claim 1 is herein amended and claims 8-12 are herein cancelled
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`without prejudice or disclaimer. New claims 18-25 are herein added.
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`No new matter has been added by way of amendment. Written support can be found
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`throughout the Specification as originally filed.
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`After entry of this amendment, claims 1-6, 13-25 are pending and under examination,
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`among which claims 1, l3 and 17 are independent claims.
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`Allowable Subject Matter
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`Applicant thanks the Examiner for finding pending claims 13-17 to be directed to allowable
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`subject matter.
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`Claim Rejection under 35 USC §101
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`Claims 1-6 stand rejected as being directed to patent ineligible subject matter.
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`Without acquiescing to the rejection and in an effort to advance the examination of the
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`present application, Applicant has amended claim 1.
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`

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`U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`Claim 1 as amended is in accordance with the current USPTO subject matter eligibility
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`guidelines (2016)(the “Guidelines”), Life Science Example 29, claims 5 and 6, and thus,
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`is
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`believed to comply with 35 USC §101.
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`In particular, claim 6 of Example 29 reads as follows:
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`“6. A method of diagnosing and treating julitis in a patient, said method
`comprising:
`a. obtaining a plasma sample from a human patient;
`b. detecting whether JUL-1 is present in the plasma sample,
`c. diagnosing the patient with julitis when the presence of JUL-1 in
`the plasma sample is detected; and
`d. administering an effective amount of anti-tumor necrosis factor
`(TNF) antibodies to the diagnosed patient.”
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`The Guidelines further states, in concluding that claim 6 is subject matter eligible, that:
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`“This claim further recites an additional element of administering an
`effective amount of anti-TNF antibodies to the diagnosed patient (step d).
`Prior to applicant’s invention, and at the time the application was filed,
`however, administering these antibodies to treat a patient diagnosed with
`julitis was well-understood, routine and conventional activity engaged in by
`doctors in the field. Further, it is well established that the mere physical or
`tangible nature of additional elements such as the obtaining, detecting, and
`administering steps does not automatically confer eligibility on a claim
`directed to an exception (see, e.g., Alice Corp, 134 S.Ct. at 2358-59).
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`When the additional elements are viewed as a combination, however, the
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`additional elements (steps a, b and d) amount to a claim as a whole that
`adds meaningful limits on the use of the exception (the correlation and
`critical thinking step). The totality of these steps including the recitation of
`a particular treatment (administration of an effective amount of anti-TNF
`antibodies) in step d integrate the exception into the diagnostic and
`treatment process, and amount to more than merely diagnosing a patient
`with julitis and instructing a doctor to generically “treat it. ” Further, the
`combination of steps, which is not routine and conventional, ensures that
`patients who have julitis will be accurately diagnosed (due to the detection
`of JUL-1 in their plasma) and properly treated with anti-TNF antibodies, as
`opposed to being misdiagnosed as having rosacea as was previously
`commonplace. See Diamond v. Diehr, 450 US. 175, 188 (1981) (“a new
`combination of steps in a process may be patentable even though all the
`constituents of the combination were well known and in common use before
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`the administration of anti-TNF
`the combination was made”). Thus,
`antibodies, when considered as a combination with the other additional
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`

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`U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`elements, yields a claim as a whole that amounts to significantly more
`than the exception itself (Step 2B: YES). The claim is eligible.
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`As set out by the Federal Circuit
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`in Vanda Pharmaceuticals Inc.
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`v. West-Ward
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`Pharmaceuticals 887 F.3d 1117 (Fed. Cir. 2018), since the claim itself is directed to patent eligible
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`subject matter, whether or not the treatment is routine or conventional is immaterial. The Vanda
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`decision has been determined to be in keeping with the USPTO subject matter eligibility guidelines
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`(2016) and confirms that 1) methods of treatment that practically apply natural relationships are
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`patent eligible, and 2) it is not necessary for methods of treatment that practically apply natural
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`relationships to include non-routine or unconventional steps in order to be patent eligible.
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`Accordingly, Applicant respectfully submits that amended claim 1 and the claims
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`dependent thereon (claims 2-6 and 18-25) comply with 35 USC §101.
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`Claim Rejection under 35 USC §103
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`Claims 8-12 are rejected as allegedly obvious over Cohen et al.
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`Without acquiescing to the rejections and in an effort to advance the examination of the
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`present application, Applicant has canceled claims 8-12. Accordingly, the instant rejection is
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`rendered moot.
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`Reconsideration and withdrawal of all rejections is respectfully requested.
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`

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`U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`CONCLUSION
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`Applicant submits that all pending claims are in condition for allowance. It is believed that
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`all pending issues have been fully addressed. However, the absence of a reply to a specific
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`rejection, issue, or comment does not signify Applicant’s agreement. In addition, because the
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`arguments made above may not be exhaustive, there may be additional reasons for patentability of
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`any or all pending claims (or other claims) that have not been expressed. Further, the amendment
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`of any claim does not necessarily signify concession of unpatentability of the claim prior to its
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`amendment.
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`The Examiner is encouraged to contact the undersigned at the telephone number listed
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`below to discuss any issue believed to be relevant to this matter.
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`Respectfully submitted,
`MILSTEIN ZHANG & WU LLC
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`By:
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`/Yin P. Zhang 44,372/
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`
`Yin Philip Zhang, Ph.D., Reg. No. 44,372
`Attorney for Applicant(s)
`Tel: (617) 529-8369
`Email: philip.zhang@mzwiplaw.com
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`Date: August 28, 2019
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`Customer Number: 88993
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`MILSTEIN ZHANG & WU LLC
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`2000 Commonwealth Ave, Suite 400
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`Newton, MA 02466
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`