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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Argument filed, 01/12/2026.
Claims 22-41 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS MAINTAINED
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, 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 22-41 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/164736 to Vidyasagar (published 2014, IDS of 10/31/2023).
Vidyasagar teaches a method of preventing and/or treating a lung complication induced by radiation, or a lung injury or a lung disease, wherein the method comprises administering to a subject in need thereof, an effective amount of a composition comprising one or more free amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, asparagine, and serine, and optionally, therapeutically acceptable carriers, electrolytes, buffering agents, and flavoring agents (pgs. 17-18, claims 1, 8).
Vidyasagar teaches the lung diseases as alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and more (pgs. 17-18, claims 7, 14).
Vidyasagar specifically exemplifies the following formulations for improving pulmonary function:
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(pg. 14).
Regarding claim 22, while Vidyasagar teaches compositions comprising one or more free amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, asparagine, and serine, and exemplifies compositions comprising combinations of these amino acids, it differs from that of instant claim 22 in that it does no teach a composition wherein the free amino acids consist of aspartic acid, serine, threonine, tyrosine, and valine.
Vidyasagar additionally teaches its compositions as comprising, consisting essentially of, or consisting of one or more amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine (pg. 2, lines 18-25; pg. 4, line 8-pg. 5, line 7).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select aspartic acid, serine, threonine, tyrosine, and valine as the amino acids in its compositions, to arrive at instant claim 22. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because Vidyasagar teaches that its therapeutic compositions for improving lung function can consist of one or more of lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine. See also KSR (E), MPEP 2143.
As such, an artisan having ordinary skill in the art would have been motivated to make such selections, to predictably arrive at a composition that is individually optimized or optimized to a specific patient population, to improve lung function in patients with alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and other lung diseases and injuries.
Regarding claim 32, while Vidyasagar teaches compositions comprising one or more free amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, asparagine, and serine, and exemplifies compositions comprising combinations of these amino acids, it differs from that of instant claim 32 in that it does no teach a composition wherein the free amino acids consist of serine, threonine, tryptophan, tyrosine, and valine.
Vidyasagar additionally teaches that its therapeutic compositions for improving pulmonary function comprises, consists essentially of, or consists of one or more amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, 8-and serine (pg. 2, lines 18-25; pg. 4, line 8-pg. 5, line 7).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select serine, threonine, tryptophan, tyrosine, and valine as the amino acids in its compositions, to arrive at instant claim 32. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because Vidyasagar teaches that its therapeutic compositions for improving lung function can consist of one or more of lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine. See also KSR (E), MPEP 2143.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a composition that is individually optimized or optimized to a patient population, to improve lung function in patients with alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and more lung diseases and injuries.
Regarding claims 23-25 and 33-35, Vidyasagar teaches:
-0.532-6.575g/l aspartic acid
-0.420-3.784 g/l serine
-0.476-4.288 g/l threonine
-0.725-6.523 g/l tyrosine
-0.469-4.217 g/l valine
-0.817-7.352 g/l tryptophan (pg. 5, line 22-pg. 6, line 13).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the amount of tyrosine in claims 25 and 35, while Vidyasagar does not teach 0.2 g/L tyrosine, Vidyasagar teaches administering an effective amount of a composition comprising tyrosine and defines “effective amount” as an amount that is capable of treating or ameliorating a disease or condition (pg. 10, lines 26-28), and teaches that each free amino acid can be present at a concentration from 0.1g/L to 8 g/L (pg. 5, lines 16-21). As such, an artisan having ordinary skill in the art would have been motivated to select 0.2g/L tyrosine as the amount of tyrosine in the composition of Vidyasagar, to predictably arrive at a therapeutically effective amount of tyrosine that improves lung function in patients with alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and more lung diseases and injuries.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 26 and 36, Vidyasagar teaches that each free amino acid can be present at a concentration from 4mM to 40mM (pg. 5, lines 16-21); in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 27 and 37, Vidyasagar teaches the free amino acids in L-form (pg. 3, lines 21-28; pg. 4, line 24-pg. 5, line 7; pg. 9, lines 9-16; pg. 14; pg. 18, claim 9).
Regarding claims 28 and 38, Vidyasagar teaches carriers as optional agents (pgs. 17-18, claims 1 and 8) and exemplifies formulations comprising carriers, buffer, adjuvant and/or excipient (pg. 14).
Regarding claims 29 and 39, Vidyasagar teaches electrolytes as optional ingredients. As such, an artisan having ordinary skill in the art would have been motivated to formulate the compositions of Vidyasagar without electrolytes to arrive at compositions that improve lung function in patients with alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and other lung diseases and injuries, because Vidyasagar teaches electrolytes as optional ingredients.
Regarding claims 30 and 40, Vidyasagar teaches humans as the subjects (pg.10, lines 29-32).
Regarding claims 31 and 41, Vidyasagar teaches oral administration (pgs. 17-18, claims 5, 12).
Response to Arguments
On pg. 7, Remarks, Applicant argues that each specific composition embodiment exemplified in Vidyasagar (i.e., compositions comprising five, eight, and nine amino acids) uniformly include lysine and glycine. Applicant argues that this consistent inclusion indicates that Vidyasagar considered lysine and glycine to be critical or indispensable to the functionality of the composition, and therefore Vidyasagar lacks any suggestion that a functional or effective composition could exist without them.
This argument has been fully considered, but is not found persuasive. Applicant is respectfully reminded that patents are relevant as prior art for all they contain and “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994),” see MPEP 2123.
Vidyasagar teaches a method of preventing and/or treating a lung complication induced by radiation, or a lung injury or a lung disease, wherein the method comprises administering to a subject in need thereof, an effective amount of a composition comprising one or more free amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, asparagine, and serine, (pgs. 17-18, claims 1, 8).
Vidyasagar exemplifies two composition comprising the instantly claimed combination of amino acids, as shown in the table on pg. 9, Remarks.
Vidyasagar additionally teaches its compositions as comprising, consisting essentially of, or consisting of one or more amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine (pg. 2, lines 18-25; pg. 4, line 8-pg. 5, line 7).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select aspartic acid, serine, threonine, tyrosine, and valine as the amino acids in its compositions, to arrive at instant claim 22. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because Vidyasagar teaches that its therapeutic compositions for improving lung function can consist of one or more of lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine. See also KSR (E), MPEP 2143.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a composition that is individually optimized or optimized to a specific patient population, to improve lung function in patients with alveolitis, pneumonitis, pulmonary fibrosis, asthma, COPD, and other lung diseases and injuries.
Moreover, as pointed out in the rejection, Vidyasagar exemplifies two compositions, wherein one comprises aspartic acid, serine, threonine, tyrosine, and valine, and the other comprises aspartic acid, serine, threonine, tyrosine, valine, and tryptophan.
Regarding the arguments toward lysine and glycine being essential to the effects of the methods of Vidyasagar, it is respectfully pointed out that Vidyasagar does not teach lysine or glycine as “critical or indispensable to the functionality of the composition,” as argued by Applicant. And Applicant has provided no data or evidence to substantiate this assertion. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record.
Moreover, regarding its examples, Vidyasagar states “Following is an example that illustrates procedures and embodiments for practicing the invention. The example should not be construed as limiting” (pg. 13, lines 25-26), and “It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application” (pg. 16, lines 1-4).
On pg. 8, Remarks, Applicant argues that the examiner’s selection of aspartic acid, serine, threonine, tyrosine, and valine or serine, threonine, tryptophane, tyrosine, and valine, is a result of cherry-picking and hindsight bias, and that the mere fact that all individual elements exist in the prior art does not make their specific combination obvious unless there is a clear reason to choose that specific subset.
These arguments have been fully considered, but are not found persuasive. As discussed above, Vidyasagar specifically teaches the instantly claimed combination of amino acids, as together, in a composition. And Vidyasagar specifically teaches that its compositions can comprise, consist essentially of, or consist of one or more amino acids selected from lysine, glycine, threonine, valine, tyrosine, aspartic acid, isoleucine, tryptophan, and serine (pg. 2, lines 18-25; pg. 4, line 8-pg. 5, line 7), in a method of preventing and/or treating a lung complication induced by radiation, or a lung injury or a lung disease. As such, an ordinary skilled artisan would reasonably be motivated to modify the combination of amino acids taught by Vidyasagar to predictably arrive at a combination that is optimized for a preventing and/or treating a lung complications induced by radiation, or a lung injury or a lung disease. Moreover, KSR(E) states that choosing from a finite number of identified, predictable solutions, i.e., 10 amino acids, with a reasonable expectation of success, i.e., treating a lung complication induced by radiation, lung injury, or lung disease, is obvious to try, and supports a conclusion of obviousness (MPEP 214).
As such, there is motivation to select the instantly claimed combination of amino acids in claims 22 and 32.
Applicant is respectfully reminded that obviousness does not require absolute predictability, but a reasonable expectation of success (MPEP 2143.02).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The instant rejection is not based on improper hindsight reasoning.
The chart on pg. 9, Remarks, has been fully addressed in the above arguments. Cols. 2 and 3 mirror Formulations 1 and 2 on pgs. 14 of Vidyasagar. Col. 1 is a reference to an embodiment on pg. 6 of Vidyasagar. It is noted that Vidyasagar teaches approximately seven additional embodiments on pgs. 3-6.
For these reasons, Applicant’s arguments are not persuasive to overcome the instant rejections.
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/apply/applying-online/eterminal-disclaimer.
Claims 22-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,576,884 (PTO-892).
‘884 claims a method for treating asthma in a subject in need thereof a formulation comprising a therapeutically effective combination of free amino acids consisting of threonine, valine, tyrosine, aspartic acid, and serine or consisting of threonine, valine, tyrosine, serine, and tryptophan (claims 1 and 11).
‘884 claims oral formulations (claims 10, 21).
‘884 claims 0.4-1.5 g/L threonine, 0.7-1.7g/L valine, 0.05-0.4g/L tyrosine, 0.4-3.6 g/L aspartic acid, 0.6-1.6 g/L serine, and 1.1-2.1 g/L tryptophan (claims 2-5, 13-16).
‘884 claims amino acids in the L-form (claims 6, 17).
‘884 claims the composition as further comprising a pharmaceutically acceptable carrier, buffer, adjuvant, or excipient (claims 7, 18).
‘884 claims the formulation does not include, or comprises only negligible amounts of electrolytes (claims 8, 19).
‘884 claims humans as the subject (claims 9, 20).
Response to Arguments
On pg. 10, Remarks, Applicant states that a Terminal Disclaimer has been submitted which renders this rejection moot. However, no Terminal Disclaimer has been filed. As such, this rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622