DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 8/10/26 has been entered in full. Claims 2 and 4-7 are amended. Claims 8 and 25-26 are canceled. Claims 1-7, 9-15 and 23-24 are pending.
Applicants' election without traverse of Group VIII, currently claims 6 and 7, was previously acknowledged. Claims 1-5, 9-15 and 23-24 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 6-7 are under consideration.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (5/14/26).
The objections to the specification at page 3 are withdrawn in view of the amendments to the specification.
All objections and/or rejections of canceled claims 8 and 25-26 are moot.
The objections to claims 6-7 at page 3 are withdrawn in view of the amendments to the claims.
The rejection of claims 6-7 at pages 3-4 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
The rejection of claims 6-7 at pages 5-8 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims that limit the administered product of the claimed method to a recombinant IL-27 protein, in accord with the scope indicated as meeting the written description requirement at page 8 of the 5/14/26 Office action.
The rejection of claims 6-7 at page 9-11 under 35 U.S.C. 102(a)(1) as being anticipated by Lei et al (2019) is withdrawn in view of the amendments to the claims that limit the claimed method to treating hypothermia in a subject in need.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.-Subject to 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 dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form 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. This rejection was set forth at pages 4-5 of the 5/14/26 Office action.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Claim 7 has been amended to change “organism” to “subject”, and to specify that the tissue or cell of the human or mammalian subject is “an in vitro tissue”. In the reply at page 8, Applicants “request withdrawal in view of the amendments to claim 7”.
This argument has been fully considered but is not found persuasive. The claim was rejected because claim 7 limited the method of claim 6 to one wherein “the organism” comprised “a human subject or tissue or cell thereof, a mammal or tissue or cell thereof, or a microorganism”, and the art-accepted definition of an organism does not encompass a “tissue or cell” derived from a human or mammal. The amendment to change “the organism” to “the subject” does not overcome this rejection because the art-accepted definition of a “subject” does not encompass “tissue or cell” derived from a human or mammal any more than the term “organism” does. The specification as originally filed does not contain a definition of the term “subject”. The first definition of the term “subject” in the Medical Dictionary at the Free Dictionary is “a person or animal subjected to treatment, observation, or experiment” (see “Definition of subject by Medical Dictionary” at https://medical-dictionary.thefreedictionary.com/subject; 1 page as printed on 10/6/26; no author indicated). Furthermore, the claims require the subject to have hypothermia, which is a condition limited to an organism having a core body temperature (see below). With respect to the further limitation limiting the “tissue or cell thereof” to “an in vitro tissue or cell thereof”, this merely incorporates the further limitation of dependent claim 8, now canceled.
As such, it remains that claim 7 is broader than parent claim 6, because claim 7 is limited to a subject but claim 7 encompasses in vitro cells or tissues derived from a subject. Therefore, dependent claim 7 is of improper dependent form for failing to further limit the subject matter of parent claim 6.
Applicants may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New Rejections Necessitated by Applicants’ Amendment
Claim Rejections - 35 USC § 112(b)
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-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 7 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 pre-AIA the applicant regards as the invention.
In claim 6, the phrase “a subject in need” is missing the word “thereof” that is required to definitively tie the subject back to the previously recited condition of hypothermia. As such, the claim is indefinite because it is unclear whether the subject is need of treatment for hypothermia or not. In this regard the claim could be rendered definite by amending the phrase “a subject in need” to “a subject in need thereof” in each of the two instances in line 4 of the claim.
In claim 7, lines 2-3 it is unclear how “an in vitro tissue or cell” of a human or mammal, or a microorganism can be in need for treatment for the condition of hypothermia. Hypothermia is recognized as “a core body temperature lower than 35°CC (95°F)” (page 1290 of Peiris et al, 2018. JAMA. 319(12): 1290). As hypothermia relates to a drop in core body temperature of an organism and tissue and cells found in vitro and microorganisms do not have a core body temperature that is regulated, such are not subject to the condition of hypothermia as appreciated medically.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
