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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/13/2025 has been entered.
Claim Status
Claims 1-7 and 11-16 are pending.
Claims 2-3 and 11-13 are withdrawn as being directed to a non-elected product/ composition invention, the election having been made on 1/27/2020. The method claims 6-7 are withdrawn as depending on the product claims 3 and 2 respectively. Claims 14-16 are further withdrawn as directed a non-elected method species. The examiner request applicant to correct the administrative error of claim status identifier of claim 14 to be consistent with claims 15-16 as “(withdrawn)”.
Claim 8-10 was cancelled.
Claims 1 and 4-5 have been examined.
Priority
This application is a 371 of PCT/IN2017/050124 filed on 04/01/2017, which claims foreign priority of INDIA 201621011729 filed on 04/02/2016.
Maintained Rejection
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention for the reasons as follows.
The specification fails to disclose representative number of heat stable with anti-pathogenesis proteins in a plant juice to support the entire genus of the heat proteins as claimed.
The specification disclosed the heat stable proteins are actually soluble in plant juice, but become water insoluble and precipitated at a higher concentration of plant juice (p12, summary of the invention, line 15-25; p29, line 18-20), named as “water insoluble concentrated mass essentially free from components soluble in the plant juice” as described in the specification (p19, line 20-23). The specification disclosed the protein molecules having molecular weight of 26 kDa or less (p13, line 5-10). The specification further disclosed the heat stable proteins can be green leafy vegetable of Methi, Trigonella foenum-graecum L, (Example 1, p27, line 1-2). The specification fails to support the entire genus of the claims because (i) the disclosed green leafy vegetable of Methi, a single species, does not represent the entire genus of a plant juice as claimed and (ii) the disclosed 26 kDa protein isolated from green leafy vegetable of Methi does not represent the entire genus of heat stable proteins with molecular weight of 26 kDa or less and with anti-pathogenesis effect as claimed. Thus, the specification fails to disclose representative number of heat stable with anti-pathogenesis proteins in a plant juice to support the entire genus of the heat proteins as claimed.
The specification fails to establish a structure and function relationship between a protein and anti-pathogenesis effect.
The specification merely disclosed an Osmotin or Osmotin-like protein with a molecular weight of 26 kDa or less having an anti-pathogenesis effect (p35, line 22-25), but the specification failed to establish a correlation between a heat stable protein structure with a molecular weight ≤ 26 kDa and anti-pathogenesis effect for the entire genus of a heat stable protein with anti-pathogenesis effect as claimed.
Because the specification fails to satisfy written description requirements described above, claims 1 and 4-5 are rejected under 35 U.S.C. 112(a).
Applicant’s Arguments
Examiner has not responded to the objection that the a "New Ground" of rejection is made (Remarks, p7, last para to p8, para 1).
Apply section 112(a) to examine claims is irrelevant, the claim does satisfy the requirement of section 112(f) thus the claims also satisfy 112(a) written description requirement (p8, para 2 to p10, whole page).
Osmotin and Osmotin-like proteins are ubiquitous in all plant species (US 7,803,854; column 9 lines 38-40)"The PR-5 proteins are a large family (24 members in Arabidopsis thaliana alone) that is ubiquitous in plants (all species screened have been reported to contain PR-5 proteins)" (Remarks, p11 to p14, para 1-2).
Response to Arguments
Applicant's arguments filed 6/13/2025 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is not persuasive because adding additional words, without deviating the rationale of the original rejection, to explain reasons to maintain the original rejection is NOT “NEW Ground of Rejection” as argued by applicant.
Applicant’s argument (ii) is not persuasive because (a) the claim scope is insufficient by the disclosure of record detailed in the rejection above and (b) there is no 112(f) rejection. Thus, any arguments based on 112(f) CANNOT overcome 112(a) rejection and should not be in response to 112(a) rejection. Applicant can amend the claims to be sufficiently supported by the disclosure of record to overcome the 112(a) rejection.
Applicant’s argument (iii) is not persuasive because the argument is not commensurate in scope with the rejected claims. None of Osmotin, Osmotin-like proteins, or PR-5 proteins found in the rejected claims.
Thus, the 112 (a) rejection is proper and will be continuously maintained until applicant amends the claim scope to be fully supported by the disclosure of record.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Savangikar et al. (WO 2014/195975 A2, cited in IDS 10/2/2018).
The broadest reasonable interpretation of claim 1 is drawn to a method of administering to a human being a heat stable protein composition isolated from a plant juice with anti-pathogenesis effect. The specification disclosed the heat stable proteins are actually soluble in plant juice, but become water insoluble and precipitated at a higher concentration of plant juice (p12, summary of the invention, line 15-25; p29, line 18-20). Thus, a heat stable protein isolated by precipitation from a plant juice and having anti-pathogenesis effect reads on the therapeutic heat stable protein as claimed.
Savangikar et al. teach a method of using a composition comprising heat stable plant proteins for anti-pathogenesis (Abstract and Claim 1). Savangikar et al. teach the use of the protein composition to treat various diseases in mammals including human being (p18, para 1). Savangikar et al. teach the therapeutic protein composition can be produced by a process of concentrating the plant juice soluble to precipitate the proteins followed by separating the precipitate of the Juice Soluble Proteins comprising heat stable proteins from other soluble components (p20, line 20-26), reading on the limitation of a water insoluble concentrated mass essentially free from components soluble in the plant juice and enriched in heat stable proteins. Savangikar et al. teach the heat stable protein composition comprises pharmaceutical excipients or other additives (p11, line 1-3). Savangikar et al. further teach administration of the heat stable protein composition to a human subject (p1, line 8; p23, line 23), reading on the limitations of claim 1.
With respect to claim 4, Savangikar et al. teach a method of using composition of claim 1 for anti-pathogenesis effect; wherein the composition is standardized for a parameter of a property of the composition that is relatable to anti-pathogenesis property or to the content of the protein molecules having molecular weight of 26 kilo Daltons (kDa) or less (Abstract, claim 2 and claim 7).
With respect to claim 5, Savangikar et al. teach the anti-pathogenesis effect comprising an anti-microbial effect on living beings including microbes or as an Adiponectin agonist effect in mammals (Abstract, claim 3).
Applicant’s Arguments
The product of Savangikar obtained by precipitation at a higher concentration of plant juice has different physical properties than the product of the product defined/disclosed in claim 1/claim 2 and claim 14: both are two different products (Remarks, p14, last para to p16, para 1).
Savangikar's anti-pathogenic 26 kD heat stable proteins are not different from the claimed anti-pathogenic 26 kD heat stable proteins: the products carrying them are different (Remarks, p16, para 2-4 to p19, para 1).
Response to Arguments
Applicant's arguments filed 6/13/2025 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s arguments (i) and (ii) are not persuasive because the arguments are not commensurate in scope with the claims. The method claim 14 as argued by applicant has been withdrawn and the limitation of claim 14 is not a part of limitation in the rejected claims. Even if a product-by-process were considered, the claims are still examined as a product (a composition) comprising the same 26 kD heat stable proteins evidenced by applicant’s admission in the argument (ii) to treat a human being in need taught by Savangikar et al. (WO 2014/195975 A2, cited in IDS 10/2/2018).
Additional References:
Maggio et al. (Mol Biol Rep. 1996: 14; 249–260) teach Large quantities of recombinant PR-5 proteins from the extracellular matrix of tobacco: Rapid production of microbial-recalcitrant proteins.
Briesewitz et al. (CA 2330611 A1) teach protein drug formulation in the form of syrups or tablet for oral administration well known in the art.
New Ground of Objection and Rejection
Claim Objections
Claims 1 and 4-5 are objected to because of the following informalities:
Claim 1 contains a comma “,” in line 1 to connect two distinct subjects of a human being and a complex phrase. The examiner recommends amendment of claim 1 as follows to overcome the objection (not necessary to overcome the independent 112(a) or 112(b) rejection).
A method of administering a composition comprising heat stable proteins isolated from a plant juice with anti-pathogenesis effect to treat a human being in need thereof.
With respect to claim 4, the phrase “The method of using composition of claim 1 for anti-pathogenesis effect;” in line 1 should be revised to “The method of claim 1; wherein”. A space is missing between “(KD” and “or” in line 4.
With respect to claim 5, the phrase “The method of using the composition of claim 1 wherein” in line 1 should be revised to “The method of claim 1; wherein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Osmotin or Osmotin-like proteins with anti-pathogenesis effect, does not reasonably provide enablement for all heat stable proteins in any plant juice. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation" analyzed as follows
(A) The breadth of the claims is much broader than the disclosure can support. The scope of claim 1 encompasses a method of administering any known and unknown heat stable proteins isolated from any plant juice able to treat any known or unknown pathogenesis in human.
(B) The nature of the invention is the use of one or more heat stable isolated from the green leafy vegetable of Methi (Trigonella foenum-graecum L) according to Example 1 (p26, line 20-25 to p27) to treat a patient shown in Example 3.
(C) The state of the prior art, Savangikar et al. (WO 2014/195975 A2, cited in IDS 10/2/2018), teaches a method of administering a composition comprising heat stable plant proteins having molecular weight of 26 kilo Daltons (kDa) or less (Abstract, claim 2 and claim 7) for anti-pathogenesis (Abstract and Claim 1).
(D) The level of one of ordinary skill does not recognize or expect all known and unknown heat stable proteins with molecular weight ≤ 26 kDa isolated from any plant juice able to contain anti-pathogenesis effect.
(E) The level of predictability in the art is low because not all heat stable proteins with molecular weight ≤ 26 kDa have anti-pathogenesis effect. One skill in the art has to isolate various known and unknown heat stable proteins from enormous plant species followed by undue number of anti-pathogenesis trials.
(F) The amount of direction provided by the inventor is limited. The specification used the same method and active ingredients of heat stable proteins having molecular weight of 26 kilo Daltons (kDa) or less taught by the cited prior art reference of Savangikar et al. (WO 2014/195975 A2, cited in IDS 10/2/2018).
(G) The existence of working examples are also taught by the cited prior art reference of Savangikar et al. (WO 2014/195975 A2, cited in IDS 10/2/2018).
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Because not all isolated heat stable proteins with molecular weight ≤ 26 kDa as claimed (claim 4) have anti-pathogenesis effect, one skill in the art has to isolate various known and unknown heat stable proteins from enormous plant species followed by undue number of anti-pathogenesis trials.
Because claims 1 and 4-5 fails to satisfy Wands factor analysis, claims 1 and 4-5 are rejected for lack of full scope enablement.
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 1 and 4-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim 1 is an omnibus type claim.
There is lacking of sufficient disclosure with correlation between a heat stable protein isolated from plant juice and the treated pathogenesis described above. Thus, it is unclear what kind of a heat stable protein is used in the method with respect to the structure of the hear stable protein and/or a specific name of the hear stable protein able to define its structure, rendering claim 1 indefinite. Furthermore, it is unclear what kind of pathogenesis is able to be treated by the heat stable protein with undefined structure and what kind of pathogenesis cannot not be treated by the heat stable protein with unknown structure; thus, claim 1 fails to point out what is included or excluded by the claim language. Claims 4-5 are rejected as depending on claim 1. "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.” See MPEP 2111.01.
Secondly, the term “enriched” in claim 1 is a relative term which renders the claim indefinite. The term “enriched” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Thirdly, the phrase “essentially free” is unclear because neither the specification nor the claim distinctly defines the phrase “essentially free” rendering the metes and bounds unclear. Claims 4-5 are rejected as depending on claim 1.
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 pre-AIA 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 reference all the limitations of the claim to which it refers.
Claim 4 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. Claim 4 disclosed anti-pathogenesis effect relatable to anti-pathogenesis property, but claim 4 fails to further limit the subject matter of anti-pathogenesis effect in claim 1 because anti-pathogenesis effect is relatable to anti-pathogenesis property. Applicant 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.
Conclusion
No claim mis allowed.
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/J.L/Examiner, Art Unit 1658
12/27/2025
/LI N KOMATSU/ Primary Examiner, Art Unit 1658