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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-2, 5-8, 13-14, 17, 21, 23-25, 28, 31-32, 35-36, 38, 40-42, 45-49) drawn to an oral pharmaceutical composition, is acknowledged. Applicants’ election for the species of parathyroid hormone, sodium starch glycolate, pharmaceutically acceptable salt of NAC and salt of a fatty acid, which reads on claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42, 45-50, is acknowledged. The claims that read on both the elected Group I and the abovementioned elected species include: claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42, 45-49. The elections were made without traverse.
Examiner’s note: The species election for therapeutically active agent is hereby withdrawn in view of the search results.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 24-25, 28 and 50 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, and non-elected species of the invention, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention, and the elected species of the invention. Applicants timely responded to the restriction/election requirement in the reply filed 2/19/26.
Accordingly, claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42 and 45-49 are under current examination.
Status of Claims
No new claim set was filed in response to the Restriction/Election requirement.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 ends in “, .”. The Examiner suggests removing the unnecessary “, “.
Appropriate correction is required.
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.
Claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42, 45-49 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.
Claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42, 45-49 are unlcear in that claim 1 recites “…wherein the ratio (by weight) of the proton accepting non-polymeric agent to the absorption enhancer is…”. The parentheses surrounding the phrase “by weight” renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). The Examiner suggests amending the claim to read “…wherein the weight ratio of the proton accepting non-polymeric agent to the absorption enhancer is…” in order to obviate the rejection.
Claim 1 recites the limitation “…wherein the ratio (by weight) of the proton accepting non-polymeric agent to the absorption enhancer is…”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites “at least one proton accepting non-polymeric agent” in line 3 which encompasses multiple proton accepting non-polymeric agents, (emphasis added). Thus, it is unclear whether just one, more than one, or all of the proton accepting non-polymeric agents are being referenced and must be calculated for the claimed weight ratio. Amending claim 1 to recite “…wherein the weight ratio of the at least one proton accepting non-polymeric agent to the absorption enhancer is…”, would overcome this rejection.
Claims 36 and 48 are rejected for the same reasons as the previous paragraph. Claim 36 recites “the proton accepting non-polymeric agent” in lines 4 and 6-7. Claim 48 recites “the proton accepting non-polymeric agent” in line 3.
Claim Rejections - 35 USC § 112(d)
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.
Claim 17 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 17 recites “…wherein the polymer is sodium starch glycolate or croscarmellose sodium” (emphasis added). However, claim 17 is dependent on claims 1 and 13-14 which requires the polymer to be a polysaccharide and wherein the polysaccharide is a starch derivative and a cellulose derivative (emphasis added). Neither sodium starch glycolate OR croscarmellose sodium are both a starch AND cellulose derivative and therefore, does not further limit the subject matter that it depends. Examiner’s note: the Applicants elected sodium starch glycolate as the polymer comprising a plurality of alkaline groups and therefore, the Examiner is going to examine the application for purposes of prior art as if claim 14 reads “a starch derivative or a cellulose derivative”. However, it is suggested to formally amend this claim in order to obviate the 112(d) rejection.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42 and 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Kidron et al. (US 2016/0058699; published: 3/3/16), as evidenced by Wellen et al. (Phys. Chem. Chem. Phys., 2017, 19, 26551) and in view of Sassene et al. (WO 2023/012263; published: Feb. 9, 2023).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kidron is directed to compositions for oral administration comprising a protein, an absorption enhancer, a protease inhibitor [Abstract].
With regards to instant claims 1-2, 5-7, 13-14, 17, 23, 31-32, 38 and 40-41, Kidron teaches a pharmaceutical composition for oral administration comprising a protein having a molecular weight of up to 100,000 Da (e.g., PTH; i.e., the claimed therapeutically active agent), a compound selected from the group consisting of N-(8-[2-hydroxybenzoyl]amino)caprylate (NAC) or a salt of said NAC (i.e., the claimed absorption enhancer comprising a substituted fatty acid or a salt thereof and elected species) [claims 1, 5, 9]. It is noted that Kidron also teaches other claimed therapeutically active agents such as GLP-1 and GLP-2 [0026]. With regards to the claimed polymer comprising alkaline groups, Kidron teaches wherein the composition can further comprise a disintegrating agent such as sodium starch glycolate [0113-0114]. With regards to the claimed proton accepting non-polymeric agent, Kidron teaches wherein the enhancer is a fatty acid such as sodium caprate (i.e., sodium decanoate) [0060].
With regards to instant claims 1 and 8, Kidron teaches that the abovementioned pharmaceutical composition comprises an amount of 2.5-99.4%, 40-60%, 50-70% or 70-99.4% by weight of an absorption enhancer (overlapping ranges) [0067]. It is noted that Kidron teaches that the pharmaceutical composition comprises a delivery effective amount of one OR more of the absorption enhances (i.e., the composition can comprise both NAC and sodium caprate).
With regards to instant claim 21, Kidron teaches sodium caprate and as evidenced by NIH, sodium caprate (i.e., sodium decanoate) has a pKa of 6.4, as evidenced by Wellen et al. (Abstract).
With regards to instant claim 36, Kidron teaches wherein the abovementioned composition increases the bioavailability of the active agent [0079-0090].
With regards to instant claim 42, Kidron teaches the same polypeptide as instantly claimed. The MPEP states the following (MPEP §2112(I)):
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
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“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
In the instant case, Kidron teaches the same polypeptide (e.g., PTH); they teach that such composition is capable and suitable for use in a pharmaceutical composition (e.g., tablet). Therefore, in view of MPEP §2112, claiming a new use/function/property for such known polypeptide (e.g., isoelectric point), which is inherently present in the prior art, does not necessarily make the claim patentable.
With regards to instant claims 45 and 49, Kidron teaches the abovementioned composition as dry oral dosage form (e.g., tablet) [0015].
With regards to instant claims 47-48, Kidron teaches wherein the amount of enhancer utilized in methods and composition is 50, 70 or 100 mg/dosage unit [0069]. It is noted again that Kidron teaches that sodium caprate is an absorption enhancer.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Kidron teach an embodiment with both PTH and NAC (or SNAC) [see claims], they do not teach a particular embodiment wherein such is also specifically combined with the claimed polymer comprising alkaline groups (e.g., sodium starch glycolate) and the claimed proton accepting non-polymeric agent (e.g., salt of a fatty acid such as sodium decanoate), as required by instant claims 1-2, 5, 13-14, 17, 23 and 31-32. It is noted that Kidron teaches that sodium starch glycolate is a suitable disintegrating agent and that sodium caprate is a suitable enhancer that can be used in the abovementioned composition.
Kidron does not teach wherein the weight ratio of the proton accepting non-polymeric agent (e.g., sodium caprate) to the absorption enhancer (e.g., SNAC) ranges from 0.2:1 to 1:1, as required by instant claim 1. Kidron does not specifically teach wherein the proton accepting non-polymeric agent (e.g., sodium caprate) is present in the composition in a concentration of at least 20 wt% of the total weight of the composition, as required by instant claim 35. However, such deficiency is cured by Sassene.
Sassene is directed to solid oral peptide formulations comprising a salt of N-[8](2-hydroxybenzoyl]amino)caprylic acid and a further absorption enhancer [Title and Abstract]. With regards to instant claim 1, Sassene teaches a tablet comprising SNAC (154.8 mg/tablet), NaC10 (i.e., sodium caprate or sodium decanoate; 145.2/tablet) and magnesium stearate (7.7 mg/tablet) [Ref-T2-B in Example 1] and furthermore teach an additional embodiment comprising SNAC (154.8 mg/tablet), NaC10 (i.e., sodium caprate or sodium decanoate; 145.2/tablet), nicotinamide (103.2 mg/tablet) and magnesium stearate (4.0 mg/tablet) [Ref-T4-C1 in Example 1]. It is noted that the weight ratio of sodium caprate to SNAC is approximately 1:1 (specifically 94:100, which is within the claimed range). Both Ref-T2-B and Ref-T4-C1 demonstrate faster disintegration than any of the compositions comprising only one of SNAC, sodium caprate or nicotinamide [Example 2]. Sassene teach that such tablets are intended to incorporate therapeutically active peptides; GLP-1 peptides are exemplified in Table 3.1.
Kidron does not teach the amount of millimoles of the alkaline groups in the unit dosage form (i.e., the abovementioned alkaline groups of the polymer; e.g., sodium starch glycolate), as required by instant claim 26.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on the teachings of Kidron, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify one embodiment of Kidron (e.g., the one recited in claims) by further incorporating sodium starch glycolate and sodium caprate to achieve the predictable result of obtaining a composition suitable for treating diabetes mellitus [Abstract]. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) [See MPEP 2144.07].
Kidron and Sassene are both directed to orally administered pharmaceutical compositions (e.g., tablets) comprising peptide based therapeutically active agents, SNAC, sodium caprate and disintegrating agents (e.g., sodium starch glycolate). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the tablet taught by Kidron to specifically add sodium caprate and SNAC in a weight ratio of approximately 1:1 to achieve the predictable result of obtaining a composition suitable for delivering a peptide based therapeutically active agent. One of ordinary skill in the art would have been motivated to do so because Sassene teach combining, for example, sodium caprate (at least 20 wt%) and SNAC (weight ratio of approximately 1:1) provides desirable disintegration times.
The amount of millimoles of the alkaline groups in the unit dosage form (i.e., the abovementioned alkaline groups of the polymer; e.g., sodium starch glycolate) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount (e.g., millimoles) in order to best achieve the desired results as such would provide advantageous biological effect. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Kidron teaches that sodium starch glycolate is a suitable disintegrating agent for the abovementioned pharmaceutical composition comprising a therapeutically active agent [0113]. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of disintegrating agent (e.g., sodium starch glycolate) would impact the efficacy in the treatment of diabetes mellitus and therefore be an optimizable variable.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 5-8, 13-14, 17, 21, 23, 31-32, 35-36, 38, 40-42 and 45-49 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
claims 1, 3-4, 7-11, 13-14, 16, 19 and 21-24 of copending Application No. 18/841,379;
claims 1, 3-4, 7-11, 13-16, 19-21 and 23 of copending Application No. 18/841,378;
claims 1, 3-4, 7-11, 13, 15-17, 19 and 21-28 of copending Application No. 18/841,377; and
claims 1, 3-4, 7-11, 13, 15-17 and 19-23 of copending Application No. 18/841,375
in view of Sassene et al. (WO 2023/012263; published: Feb. 9, 2023). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same oral pharmaceutical composition in the form of a unit dosage form (e.g., tablet) comprising a therapeutically active agent (e.g., a parathyroid hormone such as teriparatide or GLP-1 such as exenatide or GLP-2), an absorption enhancer (e.g., NAC or salt thereof, at least 50 wt%; at least 50 mg/unit dosage) and a polymer comprising a plurality of alkaline groups (e.g., wherein at least a portion of said alkaline groups are carboxylate groups in the form of a salt and in an amount of at least 0.03 millimoles/unit dosage; at least 20 wt%; e.g., a starch derivative with a pKa in the range of from 1.2-7.5). The difference is that the instant application recites an additional component to the composition: at least one proton-accepting non-polymeric agent (e.g., sodium decanoate or caprate); at least 20 wt%). However, based on the teachings of Sassene, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the tablet of ‘375, ‘377, ‘378 or ‘379 to specifically add sodium caprate to achieve the predictable result of obtaining a composition suitable for delivering a peptide based therapeutically active agent. One of ordinary skill in the art would have been motivated to do so because Sassene teach combining, for example, sodium caprate (at least 20 wt%) and SNAC provides desirable disintegration times. Thus, the instant claims and the application claims are obvious variants.
This is a provisional obviousness-type double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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