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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 6, 2026 has been entered.
Claims 1-10 are pending in this application and are examined on the merits in this office action.
Priority
4. Applicant claims foreign priority to INDIA 202121028519 (6/25/2021). The certified copy has been received by the Office. The document is in English. Therefore, the foreign priority date has been perfected. Thus, the effective filing date of instant application is June 25, 2021.
Maintained Rejections
U.S.C. 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. 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.
7. 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.
8. 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.
9. Claim(s) 1-4, 6 and 8-9 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al (US 2013/0303464, filed with IDS) in view of Jorgensen et al (Informa Healthcare, 2009, 1219-1230, filed with IDS) or Parkins et al (Reviews Research Focus, 2000, 3(4): 129-134, filed with IDS).
10. Patel et al teach stable ready-to-use pharmaceutical preparation containing Cetrorelix or its pharmaceutically acceptable salt for parenteral administration, can be prepared by using low amounts of glacial acetic acid with Cetrorelix acetate, tonicity adjusting agent and optionally other pharmaceutically acceptable excipients in water (see for example, paragraph [0024]), meeting the limitation of instant claims 1 and 6, in part. Patel et al teach that the concentration of Cetrorelix is 0.25 mg/ml or more and has a pH in between 2.5 to 5 (see paragraph [0025]). Patel et al further teach that the preferred concentration of Cetrorelix is in a range of 0.25 to 0.75 mg/ml, more preferably in a range of 0.25 to 0.5 mg/ml…(see paragraph [0035]), and the pH of the said pharmaceutical preparation is in the range of 2.5 to 5; preferably in the range of 2.8 to 3.5 (see paragraph [0036]), meeting the limitation of instant claim 1, in part. Patel et al further teach that the pharmaceutical preparation comprise tonicity adjusting agents; tonicity adjusting agents decrease the hemolysis of blood cells and reduce pain and irritation at the injection site. Tonicity adjusting agents that can be included in the said pharmaceutical preparation comprise of mannitol, lactose, dextrose, or the likes thereof. Preferred tonicity adjusting agent is mannitol (see paragraph [0037]), meeting the limitation of instant claims 1 ad 3-4, in part. Additionally, Patel et al teach that the amounts of tonicity adjusting agent used in the preparation is adjusted to obtain osmolality of the preparation in the range of 290 to 330 mOsm/Kg (see paragraph [0038]), meeting the limitation of instant claims 1 and 3, in part. Patel et al teach that the use of low amount of glacial acetic acid in the pharmaceutical preparation corresponds to around 0.1% w/v to 0.5% w/v of the preparation (see paragraph [0027]). Patel et al teach that the pharmaceutical preparation is administered parenterally…is subcutaneous administration (see paragraph [0026]), meeting the limitation of instant claim 8, in part. Patel et al further teach the following:
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(see Example 1, for example). The ratio range of Cetrorelix to acidifying agent of 0.01: 1 to about 1:1 recited in instant claim 2 and the shelf life recited in instant claim 9 are met.
Additionally, instant claim 9 recites the inherent property of the ready-to-use pharmaceutical composition. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
The difference between Patel et al and instant claims is that the reference does not teach glycine in the composition.
11. However, Jorgensen et al teach that the glycine is an excipient known to stabilize macromolecules such as peptides and proteins (see Table 1, for example). Parkins et al also teach that glycine is an excipient known to stabilize macromolecules (see p. 134, right column, Box 1). Parkins et al further teach that amino acids have been added to biopharmaceuticals for a variety of reasons…glycine, arginine and lysine have been reported to prevent aggregation…amino acids have been found to be useful as chelating agents, and may reduce surface adsorption (see p. 135, left column, “Amino acids”).
12. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Patel et al, Jorgensen et al and Parkins et al to add in glycine and additional known excipients that are known to stabilize macromolecules such as peptide and proteins. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Jorgensen et al and Parkins et al teach that amino acids have been added to biopharmaceuticals for a variety of reasons, for example, glycine, arginine and lysine have been reported to prevent aggregation. Therefore, one of ordinary skill in the art would expect the addition of glycine would stabilize the cetrorelix ready-to-use composition. Therefore, the combined art is prima facie obvious over instant claims 1-4, 6 and 8-9.
Please note: Claim 1v) recites an optional cosolvent. The broadest reasonable interpretation of instant claim 1, the cosolvent is not required for the stable ready-to-use pharmaceutical composition.
Response to Applicant’s Arguments
13. Applicant did not submit an argument with the RCE filed on March 6, 2026. Applicant argued in the after final response filed on February 6, 2026: “the present inventors discovered that even when a liquid Cetrorelix formulation appears clear, processable, and injectable, the drug can still undergo chemical degradation over time, forming a specific impurity known as L-Ala-Cetrorelix. This degradation is subtle, not visually apparent, and was not identified as a key problem in any of the cited documents.” Applicant argued that “A person of ordinary skill in the art reading Patel would therefore have reasonably concluded that acid selection alone sufficiently addresses stability concerns, thereby discouraging the inclusion of any other agent or excipient, including amino acids such as glycine…discourages further modification and therefore teaches away from adding excipients such as glycine.” Applicant argued that “Jorgensen and Parkins are review articles that list amino acids, including glycine among many excipient classes…Neither Patel nor Jorgensen or Parkins recognize this degradation pathway or suggest that glycine would control it.” Applicant argued that “The Office further considered glycine as a “known stabilizer” but this characterization oversimplifies the claimed composition and fails to address the specific technical problem solved by the claimed composition.” Applicant argued that “Patel focuses on physical degradation and teaches that acid control alone is sufficient, thereby discouraging additional stabilizers, and Jorgensen or Parkins do not suggest that glycine would suppress formation of L-Ala-Cetrorelix.”
14. Applicant’s arguments were fully responded to in the Advisory Action mailed on February 12, 2026. Applicant’s arguments have not found persuasive in the advisory action mailed on February 12, 2026. Instant claims are drawn to a product invention, not a method of making the product. Additionally, instant rejection is an obviousness type rejection (35 U.S.C. 103). Patel et al explicitly teach a stable ready-to-use pharmaceutical preparation comprising Cetrorelix or its pharmaceutically acceptable salt for parenteral administration, with low amounts of glacial acetic acid, tonicity adjusting agent and other pharmaceutically acceptable excipients in water. Patel et al teach that the concentration of Cetrorelix is 0.25 mg/ml or more and has a pH between 2.5 to 5, tonicity adjusting agents that is mannitol, lactose, dextrose, or the likes thereof (the tonicity adjusting agent is mannitol), wherein the tonicity adjusting agent used in the preparation is adjusted to obtain osmolality of the preparation in the range of 290 to 330 mOsM/Kg, and the amount of glacial acetic acid about 0.1% w/v to 0.5% w/v of the preparation. As indicated in the rejection, Example 1 of Patel et al teach a composition comprising the cited components (without the glycine), and the observation was that “the buck solution is clear, colorless with no filterability issue observed…no aggregation was observed on stability at 2-8 C and 25 C, 60% relative humidity for at least 6 months (see paragraphs [0055]-[0056]). Patel et al explicitly argue stability, and the glycine of Jorgensen or Parkins would be expected to make it even more stable, since Jorgensen et al explicitly teach that the glycine is an excipient known to stabilize macromolecules such as peptides and proteins. Parkins et al also teach that the glycine is an excipient known to stabilize macromolecules. Therefore, it would have been obvious to one of ordinary skill in the art to combine the arts to stabilize macromolecules (peptide/protein) comprising formulation by adding a well-known stabilizing agent for macromolecules. Therefore, the combined art is prima facie obvious over instant claims 1-4, 6 and 8-9. Additionally, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to provide evidence that the instant claimed formulation is markedly different from the formulation disclosed in Patel et al. In the instant case, Applicant fails to provide any direct evidence that the formulation in Patel et al comprises the impurities of L-Ala-Cetrorelix more than that is recited in the instant claims.
Therefore, the rejection is deemed to be proper and is maintained herein.
15. Claims 1-10 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (US Patent No. 7718599, cited in the previous office action) in view of Patel et al (US 2013/0303464, filed with IDS), Jorgensen et al (Informa Healthcare, 2009, 1219-1230, filed with IDS) or Parkins et al (Reviews Research Focus, 2000, 3(4): 129-134, filed with IDS) and Pedersen et al (US Patent No. 8114833, cited in the previous office action).
16. Bauer et al teach a pharmaceutical composition for parenteral administration, comprising cetrorelix acetate in a concentration of 2.5 mg/ml and a pharmaceutically acceptable acid selected from a group of gluconic acid, glucaric acid or galactouronic acid, with pH of 2.5, 2.6, 3.1, 3.7 or 4.5, which helps in suppressing aggregation of cetrorelix acetate (see claim 1, for example). Bauer et al teach that the pharmaceutical composition comprises an excipient, wherein the excipient comprises gluconic acid, glucuronic acid…citric acid, ascorbic acid, or an amino acid (see claim 3). Bauer et al further teach that the excipient comprises polyethylene glycol (see claims 4-5, for example), wherein the excipient comprises cyclodextrins or its derivatives or sugar alcohols (see claim 6), wherein the sugar alcohol is mannitol (see claim 11), wherein the pharmaceutical composition for parenteral administration is an injection preparation (see claim 12), wherein the injection preparation is for subcutaneous injection (see claim 13), wherein the excipient is independently selected from mannitol, polyethylene glycol…glycine, citric acid and cyclodextrin (see claim 14).
The difference between the reference and instant claims is that the reference does not teach 0.1 mg/ml to 0.5 mg/ml cetrorelix base or a pharmaceutically acceptable salt thereof, the amount of glycine in the range of about 1 mg/ml to about 10 mg/ml, and the propylene glycol as the cosolvent.
17. However, Patel et al teach stable ready-to-use pharmaceutical preparation containing Cetrorelix or its pharmaceutically acceptable slat for parenteral administration, can be prepared by using low amounts of glacial acetic acid with Cetrorelix acetate, tonicity adjusting agent and optionally other pharmaceutically acceptable excipients in water (see for example, paragraph [0024]). Patel et al teach that the concentration of Cetrorelix is 0.25 mg/ml or more and has a pH in between 2.5 to 5 (see paragraph [0025]). Patel et al further teach that the preferred concentration of Cetrorelix is in a range of 0.25 to 0.75 mg/ml, more preferably in a range of 0.25 to 0.5 mg/ml…(see paragraph [0035]), and the pH of the said pharmaceutical preparation is in the range of 2.5 to 5; preferably in the range of 2.8 to 3.5 (see paragraph [0036]). Patel et al further teach that the pharmaceutical preparation comprise tonicity adjusting agents; tonicity adjusting agents decrease the hemolysis of blood cells and reduce pain and irritation at the injection site. Tonicity adjusting agents that can be included in the said pharmaceutical preparation comprise of mannitol, lactose, dextrose, or the likes thereof. Preferred tonicity adjusting agent is mannitol (see paragraph [0037]). Additionally, Patel et al teach that the amounts of tonicity adjusting agent used in the preparation is adjusted to obtain osmolality of the preparation in the range of 290 to 330 mOsm/Kg (see paragraph [0038]). Patel et al teach that the use of low amount of glacial acetic acid in the pharmaceutical preparation corresponds to around 0.1% w/v to 0.5% w/v of the preparation (see paragraph [0027]). Patel et al teach that the pharmaceutical preparation is administered parenterally…is subcutaneous administration (see paragraph [0026]). Patel et al further teach the following:
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(see Example 1, for example). The ratio range of Cetrorelix to acidifying agent of 0.01: 1 to about 1:1 recited in instant claim 2 and the shelf life recited in instant claim 9 are taught.
Additionally, instant claim 9 recites the inherent property of the ready-to-use pharmaceutical composition. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
18. Jorgensen et al teach that the glycine is an excipient known to stabilize macromolecules such as peptides and proteins (see Table 1, for example). Parkins et al also teach that glycine is an excipient known to stabilize macromolecules (see p. 134, right column, Box 1). Parkins et al further teach that amino acids have been added to biopharmaceuticals for a variety of reasons…glycine, arginine and lysine have been reported to prevent aggregation…amino acids have been found to be useful as chelating agents, and may reduce surface adsorption (see p. 135, left column, “Amino acids”).
19. Furthermore, Pedersen et al teach a pharmaceutical formulations comprising a peptide and propylene glycol (see abstract, for example). Pedersen et al teach different concentration of propylene glycol (from 1 mg/ml to about 100 mg/ml) in the pharmaceutical composition (see claim 1), from about 1 mg/ml to about 50 mg/ml (see claim 2), about 5 mg/ml to about 25 mg/ml (see claim 3), from about 8 mg/ml to about 16 mg/ml (see claim 4). Pedersen et al further teach that “due to the ability of propylene glycol to reduce clogging of injection devices when compared to other isotonic agents and to mannitol in particular, in a preferred embodiment, the formulations of the invention are to be administered parenterally to a patient in need thereof…may be performed by subcutaneous, intramuscular or intravenous injection…” (see column 13, lines 43-51). Pedersen et al additionally teach that the formulation may further comprise a stabilizer selected from the group…polyethylene glycol (e.g. PEG 3350)…different salts (e.g. sodium chloride), L-glycine, L-histidine…(see column 11, lines 27-39, for example).
20. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bauer et al, Patel et al, Jorgensen et al or Parkins et al and Pedersen et al, since all references teach biopharmaceutical compositions comprising proteins. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Patel et al teach that smaller amounts/concentrations of cetrorelix acetate in glacial acetic acid at pH between 2.5 to 5 also had absence of formation of aggregates of cetrorelix acetate, Jorgensen et al and Parkins et al teach that amino acids have been added to biopharmaceuticals for a variety of reasons, for example, glycine, arginine and lysine have been reported to prevent aggregation. Furthermore, Pedersen et al teach that propylene glycol reduces clogging of injection devices when compared to other isotonic agents, one of ordinary skill in the art would be motivated to use propylene glycol as a cosolvent in injection formulations for better administration. Therefore, one of ordinary skill in the art would expect the addition of glycine would stabilize the cetrorelix ready-to-use composition and propylene glycol to reduce clogging of the formulation. Furthermore, in regards to the different concentrations of each components in the ready-to-use formulation, one of ordinary skill in the art would be motivated to optimize the concentrations of already known components for optimal formulation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). One of ordinary skill in the art would have a reasonable expectation of success, since “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”.
Therefore, the combined art is prima facie obvious over instant claims 1-10.
Response to Applicant’s Arguments
21. Applicant did not submit an argument with the RCE filed on March 6, 2026. Applicant argued in the after final response filed on February 6, 2026, “Bauer addresses instability by avoiding long-term aqueous storage altogether through lyophilization…Bauer therefore teaches away from the claimed solution and does not suggest that impurity suppression can be achieved in a liquid formulation.” Applicant argued that “Pedersen addresses an entirely different technical problem, i.e., the reduction of mechanical clogging in injection devices through the use of propylene glycol. It does not address degradation of Cetrorelix, does not discuss L-Ala-Cetrorelix, and does not suggest any relationship between its teachings and long-term impurity control in ready-to-use peptide solutions.” Applicant argued that “the cited references solve an unrelated technical problem…” In regards to claim 9, Applicant argued that “Claim 9 recites that the ready-to-use pharmaceutical composition has a shelf life of at least 24 months when stored at 2-8 C. The Applicant respectfully submits that shelf life is an emergent behavior of the finished product, determined by how the formulation controls chemical degradation pathways over time.”
22. Applicant’s arguments were fully responded to in the Advisory Action mailed on February 12, 2026. Applicant’s arguments have not found persuasive in the advisory action mailed on February 12, 2026. Again, instant claims are drawn to a product invention, not a method of making the product. Additionally, instant rejection is an obviousness type rejection (35 U.S.C. 103). Bauer et al explicitly teach a pharmaceutical composition for parenteral administration, comprising cetrorelix acetate in a concentration of 2.5 mg/ml and a pharmaceutically acceptable acid selected from a group of gluconic acid, glucaric acid or galactouronic acid, with pH of 2.5, 2.6, 3.1, 3.7 or 4.5, which helps in suppressing aggregation of cetrorelix acetate. Bauer et al teach that the pharmaceutical composition comprises…excipients…an amino acid and the excipient comprises polyethylene glycol…and is an injection preparation for subcutaneous injection. Bauer et al teach that the excipient is independently selected from mannitol, polyethylene glycol…glycine, citric acid and cyclodextrin.
As described above in the rejection, Patel et al explicitly teach a stable ready-to-use pharmaceutical composition comprising Cetrorelix or its pharmaceutically acceptable salt for parenteral administration in the amounts, osmolality and pH of instant claims. Patel et al explicitly teach a stable ready-to-use pharmaceutical preparation comprising Cetrorelix with low amounts of glacial acetic acid, tonicity adjusting agent and other pharmaceutically acceptable excipient in water. Patel et al teach that the concentration of Cetrorelix is 0.25 mg/ml or more and has a pH between 2.5 to 5, tonicity adjusting agents, and the osmolality of the preparation in the range of 290 to 330 mOsM/kg. As indicated in the rejection, Example 1 of Patel et al teach a composition comprising the cited components (without the glycine), and the observation was that “the buck solution is clear, colorless with no filterability issue observed…no aggregation was observed on stability at 2-8 C and 25 C, 60% relative humidity for at least 6 months (see paragraphs [0055]-[0056]). Patel et al explicitly argue stability, and the glycine of Jorgensen or Parkins would be expected to make it even more stable, since Jorgensen et al explicitly teach that the glycine is an excipient known to stabilize macromolecules such as peptides and proteins. Parkins et al also teach that the glycine is an excipient known to stabilize macromolecules. Therefore, it would have been obvious to one of ordinary skill in the art to combine the arts to stabilize macromolecule (peptide/protein) comprising formulation by adding a well-known glycine as an additional stabilizing agent, since Jorgensen et al or Parkins et al teach that glycine is a well-known stabilizing agent for macromolecules. Therefore, the combined art is prima facie obvious over instant claims 1-4, 6 and 8-9. Furthermore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Pedersen et al to add in the propylene glycol to reduce any clogging in the injection devices, knowing that propylene glycol reduces clogging. Additionally, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to provide evidence that the instant claimed formulation is markedly different from the formulation disclosed in Patel et al. IN the instant case, Applicant fails to provide any direct evidence that the formulation in Patel et al comprises the impurities of L-Ala-Cetrorelix more than that is recited in the instant claims. In regards to Applicant’s arguments that “shelf life is an emergent behavior of the finished product,” the Examiner maintains that claim 9 recites an inherent property of the ready-to-use pharmaceutical composition. If the combined art teaches that ready-to-use pharmaceutical composition comprising all of the active components, it would inherently have all of the activities and functionalities of instantly claimed formulation. In regards to Applicant’s argument that glycine was used as a stabilizing agent, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex. parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore, it is deemed that the combined art is prima facie obvious over instant claims 1-10. The rejection is deemed to be proper and is maintained herein.
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).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ready-to-use aqueous composition of Cetrorelix that is manufactured as a sterile liquid solution without any lyophilization followed by a reconstitution step) are not recited in the rejected claim(s). 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 combined art is prima facie obvious over instant claims 1-10. Therefore, the rejection is deemed to be proper and is maintained herein.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/10/2026
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