DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This application is a 371 of PCT/IB2021/056179. For applications filed under 371, PCT rules for lack of unity apply.
Amended claims 1, 3-6, 28, (2/6/2026), are under consideration by the Examiner.
Claims 2, 7-18 have been canceled.
Claims 19-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant’s amendment to claim 1 necessitates a new Requirement for Unity of Invention over claims 1, 3-6, and 28
Requirement for Unity of Invention
3. As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I. Claims 1, 3, 28, drawn to a pharmaceutical substance comprising a therapeutically effective amount of a genetically engineered Ksp37 protein which will translate to a Ksp37 protein wherein the composition is formulated, such as when administered to a subject one or more times over a suitable period, it raises the Ksp37 blood plasma concentration level of the subject to between 600 ng/mL and 700 ng/mL, thereby enhancing the immune response of the subject against viral infection, diseases associated with immune system disorders, and viral cancers.
Group II. Claims 1, 3-6, 28, drawn to a pharmaceutical substance comprising a therapeutically effective amount of a vector comprising a nucleic acid sequence encoding a Ksp37 protein wherein the composition is formulated, such as when administered to a subject one or more times over a suitable period, it raises the Ksp37 blood plasma concentration level of the subject to between 600 ng/mL and 700 ng/mL, thereby enhancing the immune response of the subject against viral infection, diseases associated with immune system disorders, and viral cancers.
The inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Ogawa et al (2001) discloses a genetically engineered Ksp37 protein (See abstract, lines 2-4; page 6205, column 1, second full paragraph). Thus the product of Group I lacks a special technical feature over the prior art as the reference teaches a product as recited in Group I. The Groups thus lack unity of invention over the prior art.
Telephone interview
During a telephone conversation with Alex Nie on 2/12/2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1, 3, and 28. Affirmation of this election must be made by Applicant in replying to this Office action.
Claims 4-6, and 19-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
6. Receipt of Applicant's arguments and amendments filed on 2/6/2026 is acknowledged.
7. The following previous rejections and objections are withdrawn in light of applicants amendments filed on 2/6/2026:
(i) the rejection of claims 1, 3-6, 8, and 28 under 35 U.S.C. 112(b).
Applicant's arguments with respect to the above claims have been considered but are moot in view of the new grounds of rejection over claims 1, 3, 28;
(ii) the rejection of claims 1, 3, and 28 under 35 U.S.C. 102(a)(1) as being anticipated by The Lancet (1999) as evidenced by Sidley (1997); and
(iii) the rejection of claims 1, 3-4, 8, and 28 under 35 U.S.C. 103 as being unpatentable over The Lancet (1999) in view of Okada Masaji et al (2013).
Claim Rejections - 35 USC § 101
8. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
8a. Claims 1, 3, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter and directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
This rejection is maintained for reasons of record set forth at pages 7-9 of the previous action dated 8/6/2025.
The claims recite and involve the judicial exception of natural products. The claims are directed to naturally-occurring products which encompass naturally occurring proteins and do not recite something significantly different than the naturally occurring products. The claims as a whole do not recite or include elements to the judicial exception of naturally occurring proteins that practically apply the products in a significant way by adding significantly more than the natural product and do not recite features that are markedly different from what exists in nature. The claims recite Ksp37 which is a natural product because it occurs in nature and exists in principle apart from any human action.
The claims recite Ksp37 which as explained in the specification is a nature-based product, so it is compared to its closest naturally occurring counterpart (Ksp37 in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that the claimed Ksp37 has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, the Ksp37 is a product of nature exception.
Naturally occurring proteins are not patent eligible merely because they have been isolated and the claims are drawn to a product that is a natural product that is not markedly different in structure from naturally occurring products. With respect to claims 1 and 28, the Ksp37, a man-made product is identical to the naturally occurring product Ksp37, and does not have markedly different characteristics and is not materially different. The claims therefore encompass Ksp37 that is structurally and functionally identical to naturally occurring Ksp37. Because there is no difference between the claimed and naturally occurring product, the claimed Ksp37 does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the claims are directed to a judicial exception (Step 2A: YES) of the 2014 Interim Eligibility Guidance. Because the claim does not include any additional features that could add significantly more to the judicial exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and is rejected under 35 U.S.C. § 101. For these reasons, claims 1, 3, and 28 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Applicant argues that the claimed invention does not seek to patent Ksp37 in isolation nor does it claim the mere observation of naturally occurring Ksp37 expression levels as a biological phenomenon, instead, the claims are directed to a man-made pharmaceutical composition comprising: Ksp37, wherein the composition is formulated to raise and maintain the Ksp37 blood plasma concentration level of a subject to a defined therapeutic range of 600-700 ng/mL.
Furthermore, Applicant argues that this claimed therapeutic range does not occur in nature, naturally occurring Ksp37 expression levels are transient and variable and do not result in the controlled and reproducible elevation of plasma Ksp37 levels required by the claims, in healthy adult subjects, naturally occurring Ksp37 levels are below the claimed therapeutic range, which is only achieved through deliberate formulation, dosing, and administration, in contrast to naturally varying Ksp37 levels associated with normal biology or disease, the claimed invention intentionally increases and controls Ksp37 levels to reach a therapeutic range, and the claimed composition therefore reflects human intervention and design and achieves a specific and measurable biological outcome not occurring in nature.
In addition, Applicant argues that, the claims are not "directed to" a natural product under Step 2A of the USPTO eligibility analysis, even if Ksp37 itself were considered a natural product, the claims recite additional elements that integrate any alleged judicial exception into a practical application, namely therapeutic administration formulated to achieve and maintain a defined physiological effect, Ogawa and other prior art observe Ksp37 levels during immune responses, but do not teach how to administered Ksp37 as a therapeutic agent or how to raise and control its plasma levels for therapeutic use, knowledge that Ksp37 is expressed by cytotoxic lymphocytes or involved in cell- mediated immune responses does not teach or enable how to raise, control, or maintain Ksp37 at a defined therapeutic plasma concentration, and these features amount to significantly more than any alleged judicial exception under Step 2B because Ogawa treats Ksp37 as an observed marker of immune or disease status, whereas the claimed invention employs Ksp37 as a therapeutic agent that is deliberately administered and controlled to achieve a defined physiological effect.
However, contrary to Applicant’s arguments, amended claims 1, and 28, are product claims and the newly added limitations are directed to an intended use of administration of Ksp37. Enhancing the immune response of the subject against viral infection, diseases associated with immune system disorders, and viral cancers would be an inherent property of Ksp37. Furthermore, contrary to Applicants arguments, Ogawa et al (2001), teaches that Ksp37 is selectively produced by cytotoxic lymphocytes and involved in cytotoxic lymphocyte-mediated immunity, and additionally, has clinical value as a serum indicator for monitoring cytotoxic lymphocyte levels in vivo (See abstract, page 6404, first full paragraph).
The Guidance for determining subject matter eligibility is set forth below.
Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products
http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf
Factors that weigh toward eligibility (significantly different):
a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).
d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1) for an explanation of the machine or transformation factors).
f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.
Factors that weigh against eligibility (not significantly different):
g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.
i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).
j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field.
k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s).
l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.
Contrary to Applicants arguments, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: a) the Ksp37 protein is a natural product; and b) the terms “pharmaceutical composition” or “pharmaceutically accepted excipient” comprises phosphate buffered saline (PBS) which is a buffer solution commonly used in biological research. PBS is a water-based salt solution and the osmolarity and ion concentrations of the solutions match those of the human body (isotonic). The naturally occurring Ksp37 protein in PBS maintains the activity of Ksp37 protein in its naturally occurring state. Therefore, a pharmaceutical composition comprising Ksp37 protein in PBS does not add significantly more than the naturally occurring product because the suspension of Ksp37 protein in PBS is routine and conventional.
The combination of a naturally occurring product, Ksp37 protein, and a pharmaceutically acceptable excipient, does not exhibit any markedly different properties from the individual product found in nature, nor does the specification teach or suggest that the combination exhibits different properties from the product found in nature. Thus, the claims do not recite additional elements that amount to significantly more than the judicial exception. Therefore, this rejection is maintained for reasons of record.
Claim Rejections - 35 U.S.C. § 112 second paragraph
9. 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.
9a. Claims 1, 3, and 28 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.
Claim 1 is rejected as vague and indefinite for several reasons.
Claim 1, lines 3-4, is rejected as vague and indefinite because it recites “a vector comprising a nucleic acid sequence encoding a Ksp37 protein” which is non-elected subject matter.
Furthermore, regarding claim 1, line 8, the term "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1, line 8, is rejected as vague and indefinite because it recites “administered to a subject one or more times over a suitable period” and there is no upper limit on the number of times and what a “suitable period” encompasses.
Claim 1, lines 8-12, is rejected as vague and indefinite because it recites “such as when administered to a subject one or more times over a suitable period, it raises the Ksp37 blood plasma concentration level of the subject to between 600 ng/mL and 700 ng/mL, thereby enhancing the immune response of the subject against viral infection, diseases associated with immune system disorders, and viral cancers”. Claim 1 is a product claim and there is improper recitation of a product and treatment using the product recited in the claim. The claim is a mixed claim and is confusing because it is unclear how the intended use further limits the product. The limitation “such as when administered to a subject one or more times over a suitable period, it raises the Ksp37 blood plasma concentration level of the subject to between 600 ng/mL and 700 ng/mL, thereby enhancing the immune response of the subject against viral infection, diseases associated with immune system disorders, and viral cancers” does not change the nature of a composition. Consequently, claim 1 merely further defines the intended use of the claimed product.
Claim 28 is rejected as vague and indefinite for several reasons.
Claim 28, lines 4-5, is rejected as vague and indefinite because it recites “a vector comprising a nucleic acid sequence encoding a Ksp37 protein” which is non-elected subject matter.
Claim 28, lines 6-7, is rejected as vague and indefinite because it recites “administered to a subject one or more times over a suitable period” and there is no upper limit on the number of times and what a “suitable period” encompasses.
Claim 28 is rejected as vague and indefinite because it is mixed claim comprising a product and a method of using the product and recites “a vaccine composition comprising genetically engineered Ksp37 protein; wherein the vaccine is formulated, when administered to a subject one or more times over a suitable period, to raise the Ksp37 blood plasma concentration level of the subject to between 600 ng/mL and 700 ng/mL, thereby enhancing the immune response of the subject against viral infections, diseases associated with immune system disorders, or viral cancers” which recitation is an intended use of the claimed product.
Claim 3 is rejected as vague and indefinite insofar as it encompasses all the limitations of rejected claim 1.
Claim Rejections - 35 USC § 102
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
10a. Claims 1, 3, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogawa et al (2001).
This rejection is maintained for reasons of record set forth at page 14 of the previous action dated 8/6/2025.
The reference discloses a pharmaceutical composition comprising genetically engineered Ksp37 protein in PBS (See abstract, lines 2-4; page 6405, column 1, second and fourth full paragraphs). With respect to the limitation “enhancing the immune response”, this property would be inherently possessed by the Ksp37 of the prior art.
"From the standpoint of patent law, a compound and all its properties are inseparable." In re Papesch, 315 F.2d 381, 391, 137 USPQ 43 (CCPA 1963). Therefore, the Ogawa et al reference anticipates claims 1, 3, and 28.
Conclusion
No claim is allowed.
Claims 1, 3, and 28 are rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674