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 .
Status of the Application
Claims 20-42 are pending.
Election/Restrictions
Applicant's election with no argument (i.e., without traverse) of Group I, claims 20-37, directed to a method of treating or preventing muscle atrophy, in the reply filed on 10/14/2025 is acknowledged
The requirement is therefore made FINAL.
Claims 38-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claims 20-37 are under current examination.
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 20-37 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 pre-AIA the applicant regards as the invention.
Claims 20-37 are indefinite as:
Claim 20 is indefinite as the claim recites “treating or preventing muscle atrophy----a subject suffering from sarcopenia”. The subject is already suffering from sarcopenia, a type of muscle atrophy, so it is unclear how the method is preventing a disease which was already present. Claim 20 also recites broad limitation (i.e., muscle atrophy) and narrow limitation (sarcopenia) within the same claim. It is unclear whether applicant is treating all muscle atrophy or only that related to sarcopenia. Examiner suggests reciting “A method of treating sarcopenia…” to overcome this rejection.
Since the dependent claims 21-37 doesn’t cure the above deficiency, these claims are also indefinite.
Appropriate correction required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waas (WO2015/190989 A1).
Waas discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) etc., comprising administering subcutaneously or intravenously and aqueous solution of sodium salt of dextran sulfate with an average weight in range of from 4500 to 7500Da or Mn measured by NMR spectroscopy within a range from 1850 to 2000Da with average sulfate number per glucose from 2.6 to 2.7, on average 5.1 glucose units and average sulfur content 15-20% (entire application, especially pages 9-11, 13-18, 20-40 examples and claims). Since the cited prior art reads on all of the limitations of the instant claims 20-37, these claims are anticipated.
Claims 20-37 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Lars (WO2019/050460 A1; as provided by the applicant on IDS dated 03/24/2023).
Lars discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) etc., comprising administering subcutaneously or intravenously and aqueous solution of sodium salt of dextran sulfate with an average weight in range of from 4500 to 7500Da or Mn measured by NMR spectroscopy within a range from 1850 to 2000Da with average sulfate number per glucose from 2.6 to 2.7, on average 5.1 glucose units and average sulfur content 15-20% (entire application, especially abstract, pages 1-13, 31-35, examples and claims). Since the cited prior art reads on all the limitations of the instant claims 20-37, these claims are anticipated.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 20-37 are rejected under 35 U.S.C. 103 as being unpatentable over Waas (WO2015/190989 A1).
Determining the scope and contents of the prior art
Waas discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) comprising administering subcutaneously or intravenously and aqueous solution of sodium salt of dextran sulfate with an average weight in range of from 4500 to 7500Da or Mn measured by NMR spectroscopy within a range from 1850 to 2000Da with average sulfate number per glucose from 2.6 to 2.7, on average 5.1 glucose units and average sulfur content 15-20% (entire application, especially pages 9-11, 13-18, 20-40 examples and claims).
Ascertaining the differences between the prior art and the claims at issue
Waas discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) etc., using same compound as in the instant claims. However, the cited prior art fails to give specific example of treating sarcopenia muscle atrophy.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference, Waas discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) etc., using same compound as in the instant claims. Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that any neuromuscular disease and or muscle atrophy caused by any reason such as sarcopenia (caused by aging or immobility) may be treated using dextran sulfate of the cited prior art.
Based on the above established facts, it appears that teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements modification would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Waas discloses treating muscle atrophy in neuromuscular diseases, MS, amyotrophic lateral sclerosis (ALS) comprising administering subcutaneously or intravenously and aqueous solution of sodium salt of dextran sulfate.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that sarcopenia, a muscle atrophy caused by age or immobility may be treated by dextran sulfate of the cited prior art and can be made by teachings of the above cited prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20-37 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 B2, since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application and claims 1-17 of U.S. Patent No. 11534457 B2 are drawn to a process of treating muscle atrophy using same compound and method with a difference in wording.
The difference of wording, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope claims 1-17 of U.S. Patent No. 11534457 B2. For the foregoing reasons, the instantly claimed process is made obvious.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See also MPEP § 804.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623