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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of species: a method of treating Hermansky-Pudlak syndrome comprising administering to a subject in need thereof one or more TPRII antagonists, pulmonary fibrosis, granulomatous colitis, HPS-1, HPS1, and SEQ ID NO: 18 in the reply filed 01/20/2026 is acknowledged.
Claims 2-9, 12-13, 96 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 01/20/2026.
Claims 1, 10-11, 14-15, 58, 67-68, and 87 are now under consideration in the instant Office Action.
Claim Objections
Claims 1, 10-11, 14-15, 58, 67-68, and 87 are objected to because of the following informalities: the instant claim does not explain the acronym “TβRII” at its first iteration. The acronym must be fully spelled out prior to its first iteration, after which point it may be used in place of the term it acronymizes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10-11, 58, 67-68, and 87 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.
Instant claims 10-11 recite “wherein the HPS is selected from the group consisting of HPS-1, … , HPS-10”. It is unclear what the group is listing out as the claims do not refer to the group by their shared characteristic(s). To obviate this rejection, the claim should be amended to recite “wherein the subject has a mutation of the HPS gene that is selected from the group consisting of HPS-1, … , HPS-10” to fully ascertain the genus of genetic mutations that the group belongs to.
Instant claims 58, 67-68, and 87 recite sequences for the TβRII extracellular domain. The manner in which the sequences are claimed is unclear because the claims recite any number of permutations of sequences that may begin and end at any positions from within a listed range. It is unclear what the claims are encompassing because they do not properly set out metes and bounds of what the sequences comprise.
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, 10-11, 14-15, 58, 67-68, and 87 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.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Claims 1, 10-11, and 14-15 call for a TβRII antagonist with a functional requirement of the antagonist treating Hermansky-Pudlak syndrome (HPS). There is no specific structural requirement for the TβRII antagonist beyond the required function. Further, instant claims 58, 67-68, and 87 require that the TβRII antagonist “comprises an amino acid sequence at least 80% identical to a sequence beginning at any of positions 23 to 35 of SEQ ID NO: 1 and ending at any of positions 153 to 159 of SEQ ID NO: 1 or; ii) a sequence beginning at any of positions 23 to 60 of SEQ ID NO: 2 and ending at any of positions 178 to 184 of SEQ ID NO: 2”. This reads on a large number of undisclosed permutations that can begin at any position from within the claimed range and end at any position from within the claimed range of the sequences and only retain 80% similarity to the claimed sequence. Additionally, the claims do not require the full length sequence identifier; they only require that the antagonist has an amino acid sequence with some identity to the sequence identifier. Instant claim 68 calls for a fusion protein comprising the antagonist but fails to describe what the identity of the heterologous domain the antagonist is fused to. Instant claim 1 calls for a TβRII antagonist but does not require any specific structure for this antagonist. The required function of the TβRII antagonist can be achieved in any form, no specific structure is required, as long as they treat HPS. The scope of the claim is so broad and reads on so many possible genera that it is clear that the specification fails to describe all of the possible means of achieving the response linked to its function. The claims do not require any TβRII antagonist or that they possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There are a few specific examples of TβRII antagonists in the instant specification, but there is no support provided that the Applicants have envisioned all of the possible variants encompasses by these functional requirements of the instant claims. Further, the instant claims 1, 10-11, and 14-15 does not require that the claimed antagonists possess any particular conserved structure or other disclosed distinguishing feature. The scope of the terms of the “TβRII antagonist” is so broad and reads on so many possible genera and the instant specification fails to describe any of the antagonists that are encompassed by this term. The “antagonist” encompasses any antagonist that has the required function but the instant specification fails to teach all the possible antagonists encompassed by the possible antagonists in the instant claim. The claims do not require that the “antagonist” possess any particular conserved structure or other disclosed distinguishing feature. The term “antagonist” encompasses many things including antibodies, proteins, peptides, hormones, small drugs or other drugs as long as they achieve the required function. Thus the claims are drawn to multiple genera of molecules that are defined only by they function as an antagonist. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of molecules that are encompassed by this claim.
It is appreciated that some of the claims, such as instant claims 58, 67-68, and 87, set forth some sequences and aspects of a structure for the TβRII antagonist. However, the language of the claims leaves the complete identities of the TβRII antagonists undefined as they encompass any number of permutations of sequences that may begin at any position from within a listed range, end at any position from within a listed range, and only retain 80% identity to the base sequence for the extracellular domain. The pick and choose nature of the claims give rise to a large, unknown number of molecules that can be created from this combination of selecting the identity of the extracellular domain from a significantly broader range. Applicant has not defined or shown possession of all the variants of that the instant claims encompass, nor do they properly set out the necessary information to define the complete structure of the TβRII antagonist’s extracellular domain.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. The specification does not provide a complete structure of all possible forms of the claimed antagonists and variants, and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of TβRII antagonists.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed antagonists, fragments and variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 10-11, 14-15, 58, 67-68, and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Velazquez-Diaz et al. (in instant PTO-892), in view of Kumar et al. (WO 2018204594 A1, in IDS filed 01/20/2026).
Velazquez-Diaz et al. teaches how Hermansky-Pudlak Syndrome (HPS) “is a rare, genetic, multisystem disorder characterized by oculocutaneous albinism (OCA), bleeding diathesis, immunodeficiency, granulomatous colitis, and pulmonary fibrosis. HPS pulmonary fibrosis (HPS-PF) occurs in 100% of patients with subtype HPS-1 and has a similar presentation to idiopathic pulmonary fibrosis”, see Abstract. Velazquez-Diaz et al. also acknowledges the nature of the disease, and cites the ten subtypes of HPS, HPS-1 through HPS-10, which are caused by mutations in human genes HPS1 through HPS10 Velazquez-Diaz et al. cites continued long-term study follow-up studies, which “demonstrate the efficacy and safety of pirfenidone, as pulmonary fibrosis patients are expected to receive prolonged treatment with pirfenidone”, see page 5. Pirfenidone is a well-established therapeutic with antifibrotic and anti-inflammatory properties that has demonstrated reduced fibroblast proliferation, inhibition of transforming growth factor beta (TβR), stimulated collagen production, and reduces the production of fibrogenic mediators such as transforming growth factor beta. This meets the limitations of instant claim 1 wherein HPS is treated by a TβRII antagonist, instant claims 10 and 11 wherein the mutation is an HPS-1 mutation, instant claims 14 and 15 wherein the mutation occurs in the HPS gene.
However, Velazquez-Diaz does not teach the same ΤβRΙΙ antagonist as is instantly claimed. Kumar et al. remedies this deficiency.
Kumar et al. teaches “ΤβRΙΙ fusion polypeptides comprising a heterologous portion and a truncated, ligand-binding portion of the extracellular domain of TβRII polypeptide useful to selectively antagonize a TβRII ligand… the disclosure further provides compositions and methods for use in treating or preventing ΤGFβ associated disorders”, see Abstract. Kumar et al. teaches that the TβRII antagonist is used as a “a method of treating a disease or condition associated with a TGFβ superfamily member in a patient in need thereof, the method comprising administering to the patient an effective amount of any of the polypeptides disclosed herein or any of the homodimers disclosed herein... In some embodiments, the disease or condition is a fibrotic or sclerotic disease or condition. In some embodiments, the fibrotic or sclerotic disease or condition is selected from scleroderma, lupus erythematosis, pulmonary fibrosis, …”, see page 9. The structure of the TβRII antagonist taught by Kumar et al. in SEQ ID NOs: 18 and 48 are 100% homology matches to instant SEQ ID NOs: 18 and 48, see references’ claims 71-72. This meets the limitations of instant claim 58 wherein the structure for the TβRII antagonist is taught in SEQ ID NOs: 18 and 48, instant claim 67 wherein SEQ ID NO: 18 is taught by the reference, instant claim 68 wherein a fusion protein comprises a heterologous domain, instant claim 87 wherein SEQ ID NO: 48 is taught by the reference.
It would be obvious at the time of the instant invention to use the treatment of HPS with pirfenidone taught by Velazquez-Diaz, which is an antagonist drug that has anti-fibrotic properties that results in inhibiting the conditions which worsen symptoms such as pulmonary fibrosis, with the structures and sequences taught by Kumar et al., which teach how the instantly claimed structures have been used against ΤGFβ related diseases including pulmonary fibrosis with success. One would be motivated to combine the teachings of Velazquez-Diaz et al. with the teachings of Kumar et al. with the expectation of using the TβRII antagonist as an effective treatment against the symptoms of HPS by inhibiting fibrosis and thereby ameliorating symptoms.
Therefore, claims 1, 10-11, 14-15, 58, 67-68, and 87 are rejected as obvious over Velazquez-Diaz et al. and Kumar et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Prosecution Insights