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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant elected treating lipidosis with a histatin peptide in buffer for IV administration without traverse in the reply filed on 24 July, 2025.
Claims Status
Claims 1-11 are pending.
Claims 1, 3, and 5 have been amended.
Claims 3-5 and 9-11 have been withdrawn due to an election-restriction requirement.
Withdrawn Rejections
The rejection of claims 1, 2, and 6-8 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating diseases that benefit from TMEM97 inhibition or antimicrobial activity, does not reasonably provide enablement for all lysosomal storage diseases is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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 1, 2, and 6-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, and claims dependent on it, requires one or more histatin peptides. Applicants have stated that these are small histidine rich cationic peptides found in saliva and human lacrimal epithelium (paragraph 3). The disclosure also discusses heavily modified sequences (paragraph 17), which would not be found in either saliva or human lacrimal epithelium. Applicants also discuss interfering with the TMEM97 pathway (paragraph 13); it is not clear if this is a requirement for the histatin peptide or not. In essence, applicant has a definition of a key term in the claims, and describes embodiments that do not meet that definition. This makes it unclear what is meant by the term “histatin peptides.”
response to applicant’s arguments
Applicant has amended claim 1 to require that the histatin peptides are native histatin or synthetic histatin, which they state overcomes the rejection.
Applicant's arguments filed 15 Dec, 2025 have been fully considered but they are not persuasive.
The issue is that applicants are inconsistent in how they use the term “histatin peptide.” A skilled chemist can synthesize any reasonable peptide, so this product by process limitation does not limit the claims in any way, and does not define what peptides can be used in the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Glen et al (US 20020164625) in view of Webster (North American Veterinary Conference, 2004, p501-503)).
Glen et al discuss histatin polypeptides (abstract), which are known to have potent antifungal properties (paragraph 4). This includes polypeptides (paragraph 9) and polynucleotides that encode them (paragraph 8). They can be used to treat infection from a wide range of infections, including Candida, Staphylococcus, and Streptococcus species (paragraph 15). IV administration is mentioned (paragraph 69). Formulation in a buffer for parenteral administration is mentioned (paragraph 70).
The difference between this reference and the examined claims is that this reference does not mention a lysosomal storage disease.
Webster discusses management of acute liver failure (title). One of the most common causes of this disorder is feline idiopathic hepatic lipidosis (p501, 1st column, 2nd paragraph). Patients with liver failure have increased susceptibility to infection, with Staph sp, Strep sp, Aspergillosis, and Candida being the most common infectious agents (p502, 2nd column, 4th paragraph). This reference suggests that patients with feline idiopathic hepatic lipidosis commonly have problems with infections.
Therefore, it would be obvious to treat the infected patients of Webster with the histatins of Glen et al, to treat the infections those patients have. As the common infectious agents mentioned by Webster match with the infectious agents that Glen et al states the polypeptides can treat, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Glen et al teaches that histatin peptides (applicant’s elected therapeutic) will treat a wide range of infections. Webster suggests that patients with a common form of lipidosis (applicant’s elected disorder) commonly have issues with infections, making it obvious to treat the patients of Webster with the histatin peptides of Glen et al. Thus, the combination of references renders obvious claims 1 and 8.
While none of the cited references discuss the effects of claim 2, killing a bacterial or fungal infection would reasonably be expected to reduce losses in cell viability due to the infection, rendering obvious the claim.
Glen et al discusses IV administration, which is an injection, rendering obvious claims 6 and 7.
response to applicant
Applicant argues that the rejection is not directed to treating the lysosomal storage disease.
Applicant's arguments filed 15 Dec, 2025 have been fully considered but they are not persuasive.
In the rejection, an individual with a lysosomal storage disease is treated with a histatin. While the rationale for it is different than applicant’s, a using a different rationale does not render the rejection invalid (MPEP 2144(IV)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 11,370,816 in view of D’Amico et al (Int. Ophthal. (1981) 4(1-2) p67-76).
Competing claim 1 describes a method of treating an ocular disease or condition, comprising administering a synthetic histatin peptide. Competing claim 14 describes a Markush group of disorders, including an ocular surface disease.
The difference between the competing claims and the examined claims is that the competing claims do not describe a lysosomal storage disorder.
D’Amico et al discuss lipidoses of the cornea and conjunctiva (title), the ocular surface. An example is mentioned of Fabry’s disease as a lysosomal storage disorder (p67, 2nd column, 1st paragraph). This disorder manifests as abnormal accumulation of lipids in many parts of the eye (p69, 1st column, 6th paragraph, continues to 2nd column, 1st paragraph), including tissues on the surface of the eye.
Therefore, it would be obvious to treat the Fabry’s disease of D’Amico et al with the histatin peptides of the competing claims, to treat the ocular manifestations of this disorder. As the competing claims describe a genus of disorders that include Fabry’s disease, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicant argues that Fabry’s disease are not patients that would benefit from TMEM97 antagonism, so the competing claims do not read on the examined claims as amended.
Applicant's arguments filed 15 Dec, 2025 have been fully considered but they are not persuasive.
Applicant has provided no evidence that Fabry’s disease patients will not benefit from TMEM97 antagonism. While TMEM97 is not mutated in Fabry’s disease, patients clearly have disruptions to their cholesterol pathways (Cartwright et al, J. Inherit. Metab. Dis. (2004) 27 p791-793), which is the pathway in which TMEM97 is found. It is not clear that these patients would not benefit from TMEM97 antagonism.
Examiner’s Note
As TMEM97 is known to affect cholesterol metabolism (Parente et al, J. Cell. Biochem. (2024) 125:e30645), the limitation of “benefiting from antagonizing . . . TMEM97” is considered met if the disease has aberrant cholesterol metabolism.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658