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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/08/2026 has been entered.
Claim Status
The amendment of 01/08/2026 has been entered. Claims 1-19 are pending in this US patent application. Claims 1-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claim 13 remains withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/05/2024.
Claims 12 and 14-19 are currently under examination and were examined on their merits.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2015/0071925 filed by Larson et al., published 03/12/2015.
Larson teaches liquid pharmaceutical formulations of proteins (see entire document, including page 2, paragraph 0022). The formulations are aqueous (page 9, paragraph 0102; cf. claim 12; an aqueous solution is capable of being applied to the eyes [“…ophthalmic formulation”] and contains water, which is a “lubricant” and a “carrier” and is “acceptable for ophthalmic application”). One of the proteins that can be formulated in the manner of Larson is 3K3A-APC (page 19, paragraph 0204; cf. claims 14-16; the 3K3A-APC variant fulfills the sequence identity requirements of instant claim 14). A wide variety of pharmaceutical excipients can be used in the formulations, including buffering agents, sugars, surfactants such as polysorbate-80, carriers such as PEG, and antioxidants such as ascorbic acid (pages 26-27, paragraph 0302; cf. claims 12 and 17). The buffer may be phosphate buffered saline (page 27, paragraph 0310; cf. claim 17). The concentration of the protein is between about 10-5000 mg/mL (page 3, paragraph 0023), and equivalent embodiments that may be ascertained using no more than routine experimentation are encompassed (page 42, paragraph 0455; cf. claims 18-19).
However, Larson does not explicitly teach an aqueous formulation containing 3K3A-APC, PBS, PEG, sugars, polysorbate-80, and ascorbic acid or the particular amounts of 3K3A-APC recited in instant claims 18-19.
While Larson does not explicitly teach an aqueous formulation containing 3K3A-APC, PBS, PEG, sugars, polysorbate-80, and ascorbic acid, it would have been obvious to one of ordinary skill in the art to produce such a formulation based on the teachings of Larson because Larson suggests the inclusion of all of these ingredients in protein formulations. One of ordinary skill in the art would have a reasonable expectation that combining all of these ingredients as suggested by Larson, which would intrinsically produce a “unit dosage form for application to the eye” as recited in instant claim 18, would successfully result in the production of a protein formulation that can be used to treat a patient.
The concentrations of protein recited in Larson (10-5000 mg/mL) do not overlap with the instantly recited concentration range of 0.1-8 mg/mL). However, the instantly recited amounts in claims 18-19 would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of 3K3A-APC to include in a formulation for treating patients as taught by Larson because the concentration of a protein used to treat patients is an art-recognized, result-effective variable known to affect the treatment of the relevant symptoms, which would have been optimized in the pharmaceutical art to provide the desired therapeutic effect.
Therefore, claims 12 and 14-19 are rendered obvious by Larson and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 12 and 14-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 12-14, 16, 18-23, 26-27, and 29-30 of copending Application No. 19/109083 in view of US patent application publication 2015/0071925 filed by Larson et al., published 03/12/2015. The claims of ‘083 recite a method of administering a composition comprising an APC variant, which may be the instantly recited 3K3A-APC (‘083 claim 28). The claims of ‘083 do not recite the additional ingredients recited in the instantly claimed composition. However, including these ingredients in a composition comprising 3K3A-APC is rendered obvious by Larson, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the claims of ‘083 in view of Larson and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Larson. Applicant states that Larson does not teach the use of the composition to treat ocular diseases or that the compositions are acceptable for ophthalmic administration. Applicant asserts that “‘capable of being applied to the eyes’ is not the standard for an ‘ophthalmic formulation’ or for being ‘acceptable for ophthalmic application.” Applicant states that the Larson reference is not analogous art to the claimed invention because it is not applicable to what Applicant states is the “field of endeavor” of the claimed composition. Applicant states that the Examiner has not provided a motivation to combine the ingredients recited in Larson for an ophthalmic formulation but, rather, a hindsight statement and is “picking and choosing” without a guiding principle. Applicant states that the viscosity lowering agents of Larson would interfere with the conformational integrity of the APC variants such that they could not interact with cellular receptors and induce signal transduction. Applicant states that one reading Larson would not be motivated to lower the unit dose size or the protein concentration as recited in new claims 18-19 (remarks, pages 6-13). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims are drawn to a composition, not to a method of administering a composition. Applicant’s arguments are all directed to the intended use of the composition, i.e, application of the composition to the eye. However, an intended use does not structurally limit a composition, and the structure of the composition is what is at issue in the instant claims. The Examiner further notes that the instant specification provides no definition of the terms “ophthalmic formulation” or “acceptable for ophthalmic application,” and so the Examiner must give these terms their broadest reasonable interpretation. What sorts of compositions are “acceptable” and which are not? If Applicant wishes to amend their claims to exclude particular ingredients from the claimed composition, Applicant is more than welcome to do so. However, reciting an intended use will not provide structural limitations to the claimed invention, which is a composition. For example, on page 9 of the arguments, Applicant states the following: “Ophthalmic formulations are unusually constrained: pH, osmolality, sterility, endotoxin limits, particulate control, viscosity limits, and ocular surface/retinal tolerability.” None of these parameters are limited in the instantly claimed composition. When such structural limitations or any other structural limitations regarding the claimed composition are recited in the instant claims, the Examiner will consider them with respect to the prior art, but the Examiner will not read limitations from the specification into the claims on the basis of an intended use. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 02/17/2026