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 .
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 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 8, 14, 16, 19, 20, 22, 23, 27, and 30-42 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for reducing hypersensitivity and/or treating xerostomia when administered to the oral cavity, does not reasonably provide enablement for treatment and/or prevention by administration, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to treatment and prevention of oral conditions. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Applicants specification at pages 1 and 2 which disclose the current difficulties in treatments.
The breadth of the claims
Since the instant specification provides no limiting definition of the term “prevention”, the term will be interpreted expansively. The term “prevention” may vary widely in meaning, from “preventing” a disease from occurring to “preventing” it from progressing. Nor is the term limited by any time frame.
The claims are thus very broad insofar as they suggest that one will not experience the disease when taking the claimed agent; that should one get the disease, it will not worsen; or that following its treatment, it will not recur. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
Additionally, the claims recite the term “administering” but do not require the composition claimed be administered to the oral cavity. Claim 27 has optional requirements for administration to the mouth.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for prevention or administration generally, other than administering to the mouth or oral cavity when sensitivity or xerostomia is present. The latter are corroborated by the working examples.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used prevent hypersensitivity or xerostomia by administering the composition in any manner, such as to topically to the arm, as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 102
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 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 8, 14, 16, 19, 20, 22, 23, 27, and 30-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Reynolds (WO2020/181335).
With regards to claims 8, 14, 31, 33, 40, and 42, Reynolds discloses a casein phosphopeptide composition (pg 10 lines 14-17 and pg 41, Example 1) for treatment of hypersensitivity (pg 5, lines 11-21) and xerostomia (pg 1 lines 14-15). With regards to the selection of the condition and active, where selection of one named species from a list of alternatives is all that is required to arrive at the instantly claimed subject matter, that species is anticipated. Ex Parte A., 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). See also In re Sivaramakrishnan, 213 USPQ 441 (CCPA 1982).
With regards to claims 16 and 34, fluoride ions may be present (pg 8 lines 8-25), although claim 16 has the option for the fluoride ions to either be present or not.
With regards to claims 19, 20, and 35, Example 1 appears to have 25% by weight water (pg 42) and Example 2 appears to have 55% by weight water (pg 42).
With regards to claims 22, 23, 36, and 37, the addition of known adjuvants is disclosed, including flavoring, preservative, and buffers (pg 41, lines 4-15).
With regards to claims 27 and 38, one administration appears to meet the instantly claimed times per day (see Reynolds claim 2).
With regards to claims 30, 32, and 41, the prior art composition has phosphopeptide stabilized amorphous calcium phosphate as the active, which is a derivative of casein, therefore, no additional phosphate is present.
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.
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.
Claims 8, 14, 16, 19, 20, 22, 23, 27, and 30-42 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (WO2020/181335).
The claims appear to be anticipated as discussed above, where a selection is required for the condition and active, it would have been obvious to select from the limited number of disclosed and claimed conditions based on the common mechanism of treatment. It would also have been obvious to use the preferred phosphopeptides for stabilization with the amorphous calcium phosphate.
In formulating the composition, it would have been obvious to include the various excipients taught and varying their amount based on their functional purpose, such as varying the sweetener to provide the desired taste masking properties.
Nonstatutory 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 8, 14, 16, 19, 20, 22, 23, 27, and 30-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,109,284 (‘284) in view of Reynolds (WO2020/181335). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘284 discloses a composition comprising osteopontin (claim 1) for use as an oral spray or mouth wash (claim 11), but does not claim its use to desensitize teeth or treat xerostomia. Reynolds is discussed above for teaching the use of phosphopeptides to desensitize teeth and treat xerostomia, therefore it would have been obvious to use the patented compositions for uses known suitable based on the active agent.
Claims 8, 14, 16, 19, 20, 22, 23, 27, and 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/015,926 (‘926, reference application) in view of Reynolds (WO2020/181335). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘926 discloses a composition comprising phosphopeptides (claim 1) with high water content (claim 60), but does not claim its use to desensitize teeth or treat xerostomia. Reynolds is discussed above for teaching the use of phosphopeptides to desensitize teeth and treat xerostomia, therefore it would have been obvious to use the patented compositions for uses known suitable based on the active agent.This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon-Fri (8am-5pm with occasional mid-day flex).
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.