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 .
Priority
The present application claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 63/515,944 filed 07/07/2023. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C 119 (e) or under 35 U.S.C 120, 121, or 365 (c ) is acknowledged.
Claim Status
Claims 1-21 were originally filed on 07/25/2024.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: acronym. The claim recites “PTH”; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully requests that Applicant uses “parathyroid hormone” for the first recitation, thereafter “PTH” may be utilized. Appropriate correction is required.
Claims 8-11 are objected to because of the following informalities: typographical error. The claims recite “…the subject off of standard or care”, the connecting word or should be replaced by the preposition of. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: typographical error. The claim recites “…10.6 mg/dL mg/dl.” The second recitation the unit of measurement “mg/dl” is redundant. Appropriate correction is required.
Claim Interpretation
The scope of “a PTH compound” is interpreted as open-ended requiring 100% identity with SEQ ID NO: 10 with any N-/-C terminal additions. Per MPEP 2111.03(I), the transitional phrase “has/having” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
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.
1. Claims 1-19 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 recites the limitation "… the subject…" in line 2. There is insufficient antecedent basis for this limitation in the claim. Although claim 1 is drawn to a method for management and/or treatment of hypoparathyroidism (HP) which comprises administering a dose of the PTH compound to the subject; the claim fails to recite a connection between the condition (i.e., HP) and “the subject”. Since the term “the subject” encompasses any individual, not necessarily affected by the condition of interest (i.e., HP), thus an ordinary skill artisan would not be able to ascertain the metes and bounds of the claimed method with respect to the subject population to which the method for management and/or treatment would be administered to. Claims 2-19 are included in this rejection because these claims depend upon a rejected claim.
2. Claims 6-12 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 6 recites the limitation "titrating the subject off of a standard of care treatment for HP" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends upon parent claim 1; parent claim 1 is silent about the subject receiving a standard of care treatment for HP. Therefore, an ordinary skilled artisan would not be able to ascertain the metes and bounds of the claimed method because it is uncertain whether the claimed method comprises administering a PTH compound to a subject who is also receiving the standard of care treatment for HP or whether the claimed method is only comprises administration of a PTH compound to a subject in need thereof. Claims 7-12 are rejected because of their dependency upon a rejected claim.
Claim Rejections - 35 USC § 102
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.
3. Claims 1-5 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allas et al. J Endocrine Soc, volume 5, Issue Supplement_1, April-May 2021 (herein after “Allas et al.”).
Regarding claims 1 and 18, Allas et al. disclose that hypoparathyroidism is a rare disease characterized by a deficiency in parathyroid hormone (PTH) that results in hypocalcemia and hyperphosphatemia (see pg. A254, right column, first paragraph). Allas et al. add that AZP-3601 is a novel 36 amino-acid PTH analog that has been designed to potently bind to the R0 conformation of the PTH1 receptor (see pg. A254, right column, first paragraph). AZP-3601 was administered to subjects in the morning by subcutaneous injection in the abdominal wall and was well tolerated with no remarkable adverse events (see pg. A254, right column, first paragraph); thereby corresponding to wherein the administration is y subcutaneous injection as recited in instant claim 18.
Allas et al. add that as compared with placebo controls, AZP-3601 treatment produced a clear, dose-dependent increase in mean albumin-adjusted serum calcium values from baseline (see pg. A254, right column, first paragraph). Thereby, Allas et al.’s disclosure corresponds to the instantly claimed method for management and/or treatment of hypoparathyroidism in a subject, the method comprising administering a dose of a PTH compound to the subject, as recited in instant claim 1.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because Allas et al. disclose AZP-3601 as a 36 amino-acid PTH analog. The instant specification teaches that the PTH compound is a peptide having an amino acid sequence as set forth in SEQ ID NO: 10 (AZP-3601) (see instant specification, pg. 19, para[0085]). Thereby AZP-3601 corresponds to wherein the PTH compound has an amino acid sequence as set forth in SEQ ID NO: 10, as recited in instant claim 1.
With respect to wherein the administration of the PTH compound maintains or improves bone integrity; although Allas et al. do not expressly disclose that AZP-3601 maintains or improves bone integrity, the maintenance or improvement of bone integrity does not state a condition that is material to patentability or give meaning and purpose to the manipulative steps of the method (i.e., administering a dose of a PTH compound).
The court has found that the determination of whether clauses such as “wherein” and “whereby" is a limitation in a claim is dependent on the specific facts of the case. If the “wherein" or “whereby” clause limits a process claim where the clause gives meaning and purpose to the manipulative steps, it should be given patentable weight. However, the court also found (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’”
In the instant case, the maintenance and improvement of bone integrity is an intended result of a naturally-occurring, inherent mechanism that does not give meaning and purpose to the manipulative steps of the claimed method. Accordingly, claim 1 recites an intended result (i.e., maintenance or improvement of bone integrity) that does not appear to render material to patentability.
Moreover, MPEP 2112.01 states that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the AZP-3601 corresponds to instant SEQ ID NO: 10, then it must follow that administering AZP-3601 also maintains or improves bone integrity.
Regarding claims 2-5. Allas et al. disclose that the normal physiological diurnal variation of albumin-adjusted serum calcium was gradually attenuated with 5 and 10µg AZP-3601 (see pg. A254, right column, first paragraph). The term diurnal is being interpreted as happening once every 24 hours, therefore corresponding to administration of a daily dose between 5 and 10µg of AZP-3601. Thereby, Allas et al. disclosure of diurnal adjustment of serum calcium levels anticipate the claim limitations recited in instant claim 2.
Pursuant under 2131.03(I), "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, the daily doses disclosed by Gardella fall within the claimed daily dose ranges of 10μg/day and 120μg/day, 10μg/day and 100μg/day, 10μg/day and 800μg/day as recited in instant claims 3-5, respectively. Accordingly Allas et al.’s disclosure anticipates the claim limitations recited in instant claims 1-5 and 18.
4. Claims 1-5 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,492,508 B2 date of patent Nov. 15, 2016 (herein after “Gardella”), as evidenced by GenCore Sequence Alignment instant SEQ ID NO: 10 v Gardella’s SEQ ID NO: 4, pp. 1).
For claim 1, Gardella discloses a method for treating a subject having a disease selected from the group consisting of hypoparathyroidism, hyperphosphatemia, osteoporosis, fracture repair, osteomalacia, arthritis, and thrombocytopenia, said method comprising administering a polypeptide of claim 1 to said subject in an amount sufficient to treat said disease (see column 34, claim 9).
Gardella adds that the polypeptide of claim 1, or a pharmaceutically acceptable salt thereof comprises the amino acid sequence (SEQ ID NO: 4) Ala-Val-Ala-Glu-Ile-Gln-Leu-Met-His-Gln-Arg-Ala-Lys-Trp-Ile-Gln-Asp-Ala-Arg-Arg-Arg-Ala-Phe-Leu-His-Lys-Leu-Ile-Ala-Glu-Ile-His-Thr-Ala-Glu-Ile (see column 33, claim 5). Gardella also discloses that SEQ ID NO: 4 exhibited the strongest binding to both the R0 and RG form of the receptor (see pg. 5, lines 48-50).
As evidenced by GenCore, instant SEQ IDNO 10 is 100% identical to Gardella’s SEQ ID NO: 4 (see GenCore pg. 1). Therefore, Gardella’s method of treating a subject having hypoparathyroidism comprising administering a pharmaceutically acceptable salt thereof of polypeptide represented by SEQ ID NO: 4 in an amount sufficient to treat said disease; reads on the instantly claimed method for management and/or treatment of hypoparathyroidism (HP) in a subject, the method comprising administering a dose of a PTH compound to the subject, wherein the PTH compound has an amino acid sequence as set forth in SEQ ID NO: 10.
With respect to wherein the administration of the PTH compound maintains or improves bone integrity:
Although Gardella does not expressly teach that SEQ ID NO: 4 maintains or improves bone integrity, the maintenance or improvement of bone integrity does not state a condition that is material to patentability or give meaning and purpose to the manipulative steps of the method.
The court has found that the determination of whether clauses such as “wherein” and “whereby" is a limitation in a claim is dependent on the specific facts of the case. If the “wherein" or “whereby” clause limits a process claim where the clause gives meaning and purpose to the manipulative steps, it should be given patentable weight. However, the court also found (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’”
In the instant case, the maintenance and improvement of bone integrity is an intended result of a naturally-occurring, inherent mechanism that does not give meaning and purpose to the manipulative steps of the claimed method. Accordingly, claim 1 recites an intended result (i.e., maintenance or improvement of bone integrity) that does not appear to render material to patentability.
Moreover, MPEP 2112.01 states that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the Gardella’s SEQ ID NO: 4 is 100% identical to instant SEQ ID NO: 10, then it must follow that Gardella’s method of treating hypoparathyroidism with a pharmaceutical composition comprising SEQ ID NO: 4 must also maintain or improve bone integrity.
Regarding claims 2-5, Gardella discloses that for a 50 kg human female subject, the daily dose of biologically active compound is from about 0.5 to about 50 μgs, preferably from about 3 .5 to about 10 μgs (see column 10, lines 55-58).
Pursuant under 2131.03(I), "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, the claimed daily dose ranges of 10μg/day and 120μg/day, 10μg/day and 100μg/day, 10μg/day and 800μg/day as respectively recited in instant claims 3-5, fall within the ddaily doses disclosed by Gardella. Thus Gardella’s disclosure anticipates the claim limitations recited in instant claims 2-5.
Regarding claim 17, As previously mentioned, Gardella’s method treats a subject having a disease selected from the group consisting of hypoparathyroidism and osteoporosis (see column 34, claim 9).
Regarding claim 18, Gardella claims that the route of administration is selected from the group consisting of subcutaneously intravenously, intranasally, transpulmonarily, transdermally, and orally (see column 34, claim 10). Gardella adds that Figs. 8A-8E are graphs showing blood calcium levels in mice receiving subcutaneous injections of vehicle or a 5nmol/kg SEQ ID NO: 4 (see column 6, lines 17-18 and 20).
Accordingly, the claim limitations recited in instant claims 1-5 and 17-18 are anticipated by Gardella’s disclosure.
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.
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness
(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
5. Claims 1, 6-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,492,508 B2, Date of Patent: Nov. 15, 2016 (herein after “Gardella”) as applied to claim 1 above, further in view of WO 2021/144249 A1, Publication Date: July 22, 2021 (herein after “Sprogoe”) as applied to claims 6-13 and 18-21 herewith.
Regarding claim 1, please refer to discussion of Gardella above.
Regarding claims 6-11, Gardella does not expressly teach that the method for treating a subject having hypoparathyroidism further comprises titrating the subject off of a standard of care treatment for HP from the time a first dose of the PTH compound is administered.
However, Sprogoe is in the field of PTH compounds for use in the treatment of hypoparathyroidism, wherein treatment comprises single daily administrations of the PTH compound to a patient, and titrating the patient off of standard of care within four weeks from the time the first dose of the PTH compound was administered (see front pg. Abstract). Thereby constituting the claimed limitations recited in instant claims 6 and 10.
Sprogoe also teaches that in certain embodiments the patient is titrated off standard of care within two weeks from the time the first dose of the PTH compound is administered (see pg. 35, lines 19-20). Thereby constituting the claim limitations recited in instant claim 11.
Regarding claims 7-9, it is noted that Sprogoe does not expressly teach titrating the subject off of standard of care within 12, 10, or 6 weeks, as respectively recited in claims 7-9. However, Sprogoe teaches several embodiments wherein the titration off standard of care occurs within days (i.e., 12 days or 10 days) or within weeks (i.e., 4, 3 or 2 weeks) of the first dose of PTH compound administration (see pg. 35, lines 14-23).
Sprogoe adds that Standard-of-care (SOC) for chronic HP - specifically high dose active vitamin D and calcium 25 - only corrects hypocalcemia, targeting a sCa just below or in the lower level of normal range to avoid worsening hypercalciuria, and is frequently associated with hypocalcemia prior to the next dose (see pg. 1, lines 24-27). Additionally, long-term high dose active vitamin D and calcium may produce adverse effects beyond the original problems associated with HP, including an increase in calcium x phosphate product and urinary calcium (uCa) that together may lead to nephrocalcinosis, nephrolithiasis, and renal insufficiency as well as ectopic calcifications (see pg. 1, lines 29-32). Therefore, it would greatly benefit patients if calcium homeostasis could be maintained in the absence of SOC, such as providing continuous physiological levels of PTH (see pg. 1, lines 32-34).
The titration off of standard of care treatment for HP is clearly a result specific 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. It would have been customary for an artisan of ordinary skill to determine the optimal number of weeks needed to titrate the subject off of standard of care treatment for HP from the time a first dose of the PTH compound is administered. Thus, an ordinary skilled artisan would have been motivated to modify the number of weeks as taught by Sprogoe, for titrating a patient off of standard care. An ordinary skilled artisan would have been able to utilize the teachings of Sprogoe to obtain various transitional times parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the number of weeks for titrating the subject off of standard of care treatment for HP would have been obvious at the time of Applicants' invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
From the teachings of the references, the Examiner recognizes that 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 combine the teachings of Gardella with the teachings of Sprogoe in order to arrive at the claimed method. One of ordinary skill in the art would have been motivated to do so because a polypeptide or a pharmaceutically acceptable salt thereof comprising an amino acid sequence 100% identical to instant SEQ ID NO: 10, (i.e., (SEQ ID NO: 4) Ala-Val-Ala-Glu-Ile-Gln-Leu-Met-His-Gln-Arg-Ala-Lys-Trp-Ile-Gln-Asp-Ala-Arg-Arg-Arg-Ala-Phe-Leu-His-Lys-Leu-Ile-Ala-Glu-Ile-His-Thr-Ala-Glu-Ile) was known to be used in a method for treating hypoparathyroidism and because it exhibited the strongest binding to both the R0 and RG form of the PTH receptor as taught by Gardella. Because it was also known that standard of care for HP only corrects hypocalcemia; additionally, long-term high dose active vitamin D and calcium may produce adverse effects beyond the original problems associated with HP such as nephrocalcinosis, nephrolithiasis, and renal insufficiency as well as ectopic calcifications as taught by Sprogoe.
One of ordinary skill in the art would have had a reasonable expectation of success in achieving the claimed method given that Gardella’s method is drawn to treating a subject having hypoparathyroidism, wherein a peptide having a sequence that is 100% identical to instant SEQ ID NO: 10, is administered to the subject in an amount of sufficient to treat hypoparathyroidism. And given that Sprogoe’s method includes PTH compounds for use in the treatment of hypoparathyroidism in addition to titrating the patient off of standard of care within four weeks from the time the first dose of PTH compound is administered. As such, combining the method of Gardella with the method of Sprogoe would support the instantly claimed method of treatment by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention, pursuant to KSR.
Regarding claims 12-13, Sprogoe teaches that active vitamin D and calcium were progressively reduced, while rhPTH(1-84) could be titrated up from 50 μg to 75 μg and then 100 μg during a titration period of 5 weeks (see pg. 2, lines 29-31). Sprogoe also reports that patients randomized to compound 1 were able to discontinue oral active vitamin D. Similarly, these patients were able to stop therapeutic doses of oral calcium, and oral calcium intake was reduced from a mean of 2213 mg/day at baseline to a mean of 560 mg/day after 4 weeks of dosing with compound 1 (see pg. 88, lines 9-13).
With respect to the stable albumin-corrected serum calcium level; Sprogoe teaches that in certain embodiments, titrating off of standard of care refers to removing oral calcium and active vitamin D supplementation in case of a daily nutritional calcium uptake of >750 mg/day and in case of a daily nutritional uptake of ≤750 mg/day refers to the removal of oral active vitamin D administration and a reduction in calcium supplement to ≤1000mg/day, in certain embodiments to ≤630 mg/day, in certain embodiments to ≤500 mg/day while maintaining normal serum calcium levels (8.3 to 10.6 mg/dL or 2.075 to 2.65 mmol/L). (see pg. 3 lines 1-2; and pg. 4, lines 1-4).
Sprogoe adds that the normal level corresponds to a serum calcium level of above 8.5 mg/dL (albumin-adjusted)(see pg. 4, lines 9-10); and that the term "albumin-adjusted'' with regard to calcium levels means that the measured serum calcium level is corrected for calcium bound to albumin according to the following formula: albumin-adjusted serum calcium (mg/dL) = measured total Ca (mg/dL) + 0.8 (4.0 - serum albumin [g/dL]). (see pg. 4, lines 16-21).
Pursuant under 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the claimed albumin-corrected serum calcium level would have been obvious to one of ordinary skill in the art since the prior art adjusted calcium level (i.e., 8.5 mg/dL) lies within the claimed albumin-corrected serum calcium level (i.e., 8.3mg/dL and 10.6 mg/dL).
Regarding claims 18-19, Sprogoe’s teaches that the PTH compound is administered by subcutaneous injection with a pen injector (see pg. 92, claims 7-8).
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 U.S C 103.
6. Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/144249 A1, Publication Date: July 22, 2021 (herein after “Sprogoe”) in view of US 9,492,508 B2, Date of Patent: Nov. 15, 2016 (herein after “Gardella”), as evidenced by GenCore Sequence Alignment instant SEQ ID NO: 10 v Gardella’s SEQ ID NO: 4, pp. 1).
Regarding claim 20, Sprogoe claims a PTH compound for use in the treatment of hypoparathyroidism, wherein the treatment comprises single daily administrations of the PTH compound to a patient and titrating the patient off of standard of care within four weeks from the time the first dose of the PTH compound was administered (see pg. 92, claim 1). Sprogoe adds that the single daily dose of the PTH compound is below 31µg/day (see pg. 92, claim 4); and also claims that the single daily dose of the PTH is selected from 15µg/day, 18µg/day and 21µg/day (see pg. 92, claim5).
MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, the claimed dose of a PTH compound would have been obvious to one of ordinary skill in the art since the prior art range (i.e., below 31µg/day, and 15µg/day, 18µg/day and 21µg/day) lies within the claimed dosage range (i.e., between 10µg/day and 120µg/day).
However, Sprogoe does not expressly teach that the PTH compound has an amino acid sequence as set forth in SEQ ID NO: 10.
Gardella teaches a method for treating a subject having a disease selected from the group consisting of hypoparathyroidism, said method comprising administering a polypeptide (see column 34, claim 9). Wherein said polypeptide comprises the amino acid sequence (SEQ ID NO: 4) Ala-Val-Ala-Glu-Ile-Gln-Leu-Met-His-Gln-Arg-Ala-Lys-Trp-Ile-Gln-Asp-Ala-Arg-Arg-Arg-Ala-Phe-Leu-His-Lys-Leu-Ile-Ala-Glu-Ile-His-Thr-Ala-Glu-Ile (see column 33, claim 5). As evidenced by GenCore, instant SEQ IDNO 10 is 100% identical to Gardella’s SEQ ID NO: 4 (see GenCore pg. 1). Therefore, Gardella’s SEQ ID NO: 4 reads on the instantly claimed PTH compound having an amino acid sequence as set forth in SEQ ID NO: 10. Thus, the combined teachings of Sprogoe and Gardella are suggestive of the pharmaceutical composition recited in instant claim 20.
As such, 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 substitute Sprogoe’s PTH compound with Gardella’s SEQ ID NO: 4 in order to arrive at the claimed pharmaceutical composition. Given the teaching of the prior art and the level of the ordinary skilled artisan at the time of Applicants’ invention, it must be considered, absent evidence to the contrary that said skilled artisan would have had a reasonable expectation of success in practicing the instantly claimed invention. Substitution of Sprogoe’s PTH compound with Gardella’s SEQ ID NO: 4 would have amounted to a simple substitution of one known element for another. Additionally, it would have been predictable that Gardella’s SEQ ID NO: 4 would have been included in a pharmaceutical composition because Gardella’s SEQ ID NO: 4 exhibits strong binding affinity to both the R0 and RG form of the PTH receptor, and is also 100% identical to instant SEQ ID NO: 10.
Regarding claim 21, Sprogoe teaches that the administration of the PTH compound is with a pen injector (see pg. 92, claim 8). Therefore, it must necessarily follow that the pharmaceutical composition is comprised within an injectable pen. Accordingly, the teachings of Sprogoe when combined with the teachings of Gardella are suggestive of the claim limitations recited in instant claims 20-21.
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 before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654
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