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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/2026 has been entered.
DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Final office action filed on 2/2/2026 is acknowledged.
3. Claim filed on 2/2/2026 is acknowledged.
4. Claims 1-26, 28, 32, 33, 35, 37, 39, 40 and 45 have been cancelled.
5. New claim 56 has been added.
6. Claims 27, 29-31, 34, 36, 38, 41-44 and 46-56 are pending in this application.
7. Claims 41-43 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 27, 30, 31, 34 and 36 have been withdrawn by Applicant, which is further confirmed during an interview held with Applicant’s representative, Charles C. Yang, on 3/7/2025 (see PTO-413 dated 3/13/2025). Claims 52 and 53 remain withdrawn from consideration as being drawn to non-elected species.
8. Applicant elected without traverse of Group 4 (claims 27, 29-31, 34, 36 and 46-55) and elected the recombinant FSH-beta subunit of SEQ ID NO: 4 as species of recombinant FSH beta-subunit in the reply filed on 3/4/2025.
Restriction requirement was deemed proper and made FINAL in the previous office actions. Group 4 is drawn to a method of inducing follicle growth and/or maturation in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a modified follicle-stimulating hormone beta-subunit (rFSHβ), wherein the modified rFSHβ comprises an amino acid substitution at a glycosylation site of wild-type rFSHβ, wherein the amino acid at the glycosylation site is substituted with an amino acid at which a glycan is not and/or cannot be attached, and wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than the wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24). A search was conducted on the elected species; and prior art was found. Claims 27, 30, 31, 34 and 36 have been withdrawn by Applicant. Claims 52 and 53 remain withdrawn from consideration as being drawn to non-elected species. Claims 29, 38, 44, 46-51 and 54-56 are examined on the merits in this office action.
Withdrawn Objections
9. Objection to claims 29, 46, 47, 49 and 54 is hereby withdrawn in view of Applicant's amendment to the claim.
Maintained Objections
10. Claim 50 remains objected to for the following minor informality: Applicant is suggested to amend claim 50 as "…wherein the modified rFSHβ comprises the amino acid sequence that is…”.
Response to Applicant's Arguments
11. Applicant argues that “Applicant questions whether there is sufficient antecedent basis for the suggested amendment.”
12. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the objection to instant claim 50, this is due to an internal memo regarding how to interpret the term “an amino acid sequence” recited in claims. In the instant case, based on the internal memo, the term “an amino acid sequence” broadly includes both full-length and any fragment of the amino acid sequence that is at least 90% identical to the amino acid sequence of instant SEQ ID NO: 3 or 4. Therefore, in this case, there is no antecedent basis for the suggested amendment. And the objection is deemed proper and is hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 103
13. 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.
14. 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.
15. (Revised due to Applicant’s amendment to the claim) Claims 29, 38, 44, 46-51 and 54-56 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Pang (Women's Health, 2005, 1, pages 87-95, cited and enclosed in the previous office actions) in view of Flack et al (The Journal of Biological Chemistry, 1994, 269, pages 14015-14020, filed with IDS), and as evidenced by the Follitropin beta chain document (pages 1-2, cited and enclosed in the previous office actions, 2024, from https://www.ncbi.nlm.nih.gov/protein/1XWD_B?report=genbank&log$=protalign&blast_rank=1&RID=X7ZWKG7N016).
The instant claims 29, 38, 44, 46-51 and 54-56 are drawn to a method of inducing follicle growth and/or maturation in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a modified follicle-stimulating hormone beta-subunit (rFSHβ), wherein the modified rFSHβ comprises an amino acid substitution at a glycosylation site of wild-type rFSHβ, wherein the amino acid at the glycosylation site is substituted with an amino acid at which a glycan is not and/or cannot be attached, and wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than the wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24).
Pang, throughout the literature, teaches follicle-stimulating hormone (FSH) stimulates the growth of the preantral follicle and maturation of the preantral follicle into the preovulatory follicle; and the use of FSH, such as recombinant human FSH (rhFSH), as a therapeutic agent in women for the medical management of infertility, for example, Title; Abstract; page 87, right column, the 1st paragraph and left column, the 1st paragraph in Section “Role of FSH in folliculogenesis”; page 88, Table 1; and pages 88-93, Section “Use of FSH for the medical management of female infertility”. Therefore, in view of the teachings of Pang as a whole, one of ordinary skilled in the art would immediately envision a method of inducing follicle growth and/or maturation in a human female subject suffering infertility, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of rhFSH and a pharmaceutically acceptable carrier. It meets the limitation of the subject recited in instant claims 29, 38, 44 and 56; and the limitations of pharmaceutical composition and a pharmaceutically acceptable carrier recited in instant claim 55.
The difference between the reference and instant claims 29, 38, 44, 46-51 and 54-56 is that the reference does not teach the recombinant FSH-beta subunit of SEQ ID NO: 4 as the elected species of recombinant FSH beta-subunit; the limitation of the recombinant FSH beta-subunit recited in instant claims 29, 46-51 and 54-56; the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FHSβ” recited in instant claim 29; and the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than a fully glycosylated FSHβ (FSH24)” recited in instant claim 56.
However, Flack et al, throughout the literature, teach modified recombinant human FSH-beta subunit (rhFSHβ), wherein the amino acid at position 7, 24 or both 7 and 24 of rhFSHβ is substituted with Gln, for example, Abstract; and pages 14016-14017, Section “hFSH Glycosylation Mutants”. And as evidenced by the Follitropin beta chain document, hFSHβ in Flack et al consists of the amino acid sequence that is identical to instant SEQ ID NO: 2 (see for example, the amino acid sequence on page 2). Therefore, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in Flack et al is identical to the recombinant FSH-beta subunit of instant SEQ ID NO: 4. It reads on the recombinant FSH-beta subunit of SEQ ID NO: 4 as the elected species of recombinant FSH beta-subunit. Flack et al further teach that in comparison to wild type rhFSH, the rhFSH comprising βGln24 exhibits increased receptor binding affinity, lower EC50 (potency) and almost identical intrinsic activity, for example, page 14017, Table 1; and page 14018, Table 2.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Pang and Flack et al to develop a method of inducing follicle growth and/or maturation in a human female subject suffering infertility, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a modified rhFSH and a pharmaceutically acceptable carrier, and wherein the modified rhFSH comprises a modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24).
With regards to the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FHSβ” recited in instant claim 29; and the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than a fully glycosylated FSHβ (FSH24)” recited in instant claim 56, in the instant case, since the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above reads on the recombinant FSH-beta subunit of instant SEQ ID NO: 4 as the elected species of rFSHβ and meets all the structural limitations of the modified rFSHβ recited in instant claims 29 and 56, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above would necessarily have the same properties and functionality of the modified rFSHβ recited in instant claims 29 and 56. Therefore, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above would have the property that is more effective at inducing follicle growth and/or maturation than wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24). Furthermore, the MPEP states “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
One of ordinary skilled in the art would have been motivated to combine the teachings of Pang and Flack et al to develop a method of inducing follicle growth and/or maturation in a human female subject suffering infertility, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a modified rhFSH and a pharmaceutically acceptable carrier, wherein the modified rhFSH comprises a modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24), and wherein the modified rhFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24), because Flack et al, throughout the literature, teach modified recombinant human FSH-beta subunit (rhFSHβ), wherein the amino acid at position 7, 24 or both 7 and 24 of rhFSHβ is substituted with Gln. Flack et al further teach that in comparison to wild type rhFSH, the rhFSH comprising βGln24 exhibits increased receptor binding affinity, lower EC50 (potency) and almost identical intrinsic activity.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Pang and Flack et al to develop a method of inducing follicle growth and/or maturation in a human female subject suffering infertility, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a modified rhFSH and a pharmaceutically acceptable carrier, wherein the modified rhFSH comprises a modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24), and wherein the modified rhFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24).
Response to Applicant's Arguments
16. Applicant argues that “the rFSHβ of Flack cannot be identical to the rFSHβ as instantly claimed, as Flack fails to teach an rFSHβ in which glycosylation sites are mutated/abolished that is more effective at inducing steroidogenic/estradiol response, more effective at inducing follicle growth, and/or promoting superior bone health, such as with the rFSHβ of the instant claims.”; and “a person of ordinary skill in the art, in reading Flack, and prior art as a whole, would be dissuaded from using hypoglycosylated rFSHβ over wild-type FSH/fully glycosylated FSH (FSH²⁴) as a therapeutic for inducing follicle growth, steroidogenic response, thereby teaching
away from using hypoglycosylated rFSHβ for such therapeutic purposes in the presently claimed invention.”
17. Applicant's arguments have been fully considered but have not been found persuasive.
First, the Examiner would like to point out that instant claims 29, 38, 44, 46-51, and 54-56 are rejected under 35 U.S.C. 103 (obviousness type); and the rejection is based on the combined teachings of Pang and Flack et al. Therefore, it is not necessary for each of the cited prior art references to teach all the limitations of instant claims 29, 38, 44, 46-51 and 54-56. Furthermore, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
In response to Applicant’s arguments that “the rFSHβ of Flack cannot be identical to the rFSHβ as instantly claimed, as Flack fails to teach an rFSHβ in which glycosylation sites are mutated/abolished that is more effective at inducing steroidogenic/estradiol response, more effective at inducing follicle growth, and/or promoting superior bone health, such as with the rFSHβ of the instant claims”:
First, the Examiner understands that the cited references do not explicilty teach the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FHSβ” recited in instant claim 29; and the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than a fully glycosylated FSHβ (FSH24)” recited in instant claim 56. However, in the instant case, as stated in Section 15 above, with regards to the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FHSβ” recited in instant claim 29; and the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than a fully glycosylated FSHβ (FSH24)” recited in instant claim 56, since the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above reads on the recombinant FSH-beta subunit of instant SEQ ID NO: 4 as the elected species of rFSHβ and meets all the structural limitations of the modified rFSHβ recited in instant claims 29 and 56, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above would necessarily have the same properties and functionality of the modified rFSHβ recited in instant claims 29 and 56. Therefore, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in the method developed from the combined teachings of Pang and Flack et al above would have the property that is more effective at inducing follicle growth and/or maturation than wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24). Furthermore, the MPEP states “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. And in the instant case, Applicant fails to provide any evidence to prove otherwise.
Second, as stated in both Section 15 and the paragraph above, the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in Flack et al is identical to the recombinant FSH-beta subunit of instant SEQ ID NO: 4. Therefore, it is unclear to the Examiner how and/or why the modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) in Flack et al would not inherently have the same properties and/or functionality of the recombinant FSH-beta subunit of instant SEQ ID NO: 4. Further clarification is required. In addition, the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II).
Third, the Examiner understands that Flack et al do not provide any data showing the effect of the modified rhFSH comprises a modified rhFSHβ with the amino acid at position 24 substituted with Gln (βGln24) on inducing follicle growth and/or maturation. However, in the instant case, it appears to the Examiner that Applicant has identified latent properties of the modified rFSHβ recited in instant claims 29 and 56. And as stated in MPEP: “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention…” (see MPEP § 2145 II).
In response to Applicant’s arguments that “a person of ordinary skill in the art, in reading Flack, and prior art as a whole, would be dissuaded from using hypoglycosylated rFSHβ over wild-type FSH/fully glycosylated FSH (FSH²⁴) as a therapeutic for inducing follicle growth, steroidogenic response, thereby teaching
away from using hypoglycosylated rFSHβ for such therapeutic purposes in the presently claimed invention”, the Examiner understands that Flack et al discuss the effects of deglycosylation of wild type hFSH on receptor binding and signal transduction; and such effects could be different for each glycosylation site of the wild type hFSH. However, in the instant case, the Examiner would like to point out that as stated in Section 15 above, Flack et al explicilty teach that in comparison to wild type rhFSH, the rhFSH comprising βGln24 exhibits increased receptor binding affinity, lower EC50 (potency) and almost identical intrinsic activity. Therefore, in view of the teachings of Flack et al as a whole, in particular the teachings of Flack et al regarding the rhFSH comprising βGln24, and in view of the combined teachings of Pang and Flack et al, one of ordinary skilled in the art would have been motivated to develop the methods recited in instant claims 29, 38, 44, 46-51 and 54-56.
Taken all these together, the rejection is still deemed proper and is hereby maintained.
Obviousness Double Patenting
18. 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 claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
19. (Revised due to Applicant’s amendment to the claim) Claims 29, 38, 44, 46-51 and 54-56 remain/are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230.
20. Instant claims 29, 38, 44, 46-51 and 54-56 are drawn to a method of inducing follicle growth and/or maturation in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a modified follicle-stimulating hormone beta-subunit (rFSHβ), wherein the modified rFSHβ comprises an amino acid substitution at a glycosylation site of wild-type rFSHβ, wherein the amino acid at the glycosylation site is substituted with an amino acid at which a glycan is not and/or cannot be attached, and wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than the wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24).
21. Claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230 are drawn to a recombinant Follicle-Stimulating Hormone (FSH) beta-subunit, wherein a glycosylation site on the beta-subunit is substituted with an amino acid at which a glycan is not and/or cannot be attached; a pharmaceutical composition comprising such FSH beta-subunit and a pharmaceutically acceptable carrier; and various methods of using such pharmaceutical composition.
In the instant case, in view of the combined teachings of claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230, it would have been obvious to one of ordinary skilled in the art to develop a method of inducing follicle growth and/or maturation in a human female subject suffering infertility, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a modified rhFSH and a pharmaceutically acceptable carrier, wherein the modified rhFSH comprising a modified rhFSHβ with a glycosylation site substituted with an amino acid at which a glycan is not and/or cannot be attached, including the modified rhFSHβ of instant SEQ ID NO: 3 or 4.
With regards to the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than wild-type FHSβ” recited in instant claim 29; and the limitation “wherein the modified rFSHβ is more effective at inducing follicle growth and/or maturation than a fully glycosylated FSHβ (FSH24)” recited in instant claim 56, in the instant case, since the modified rFSHβ in the method developed from the combined teachings of claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230 above meets all the structural limitations of the modified rFSHβ recited in instant claims 29 and 56, the modified rFSHβ in the method developed from the combined teachings of claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230 above would necessarily have the same properties and functionality of the modified rFSHβ recited in instant claims 29 and 56. Therefore, the modified rFSHβ in the method developed from the combined teachings of claims 1-11, 33, 35, 37-39 and 47 of co-pending Application No. 18/863230 above would have the property that is more effective at inducing follicle growth and/or maturation than wild-type FSHβ and/or a fully glycosylated FSHβ (FSH24). Furthermore, the MPEP states “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
22. Applicant argues that “Applicant respectfully requests that the rejection be held in abeyance, if not withdrawn at this time.”
23. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the ODP rejection, until a proper terminal disclaimer is filed and approved by the Office, the double patenting rejection is maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
24. 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.
25. Claim 56 is 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.
26. Claim 56 recites the parenthetical expression “a fully glycosylated FSHβ (FSH24)”. In the instant case, based on the disclosure of instant specification, FSH24 is a fully glycosylated huma FSH (see for example, page 2, paragraph [0006] of instant specification”. Therefore, the metes and bounds of claim 56 is rendered vague and indefinite by the parenthetical recitation of “(FSH24)” because it is unclear as to whether the fully glycosylated FSHβ in instant claim 56 is limited to FSH24 or not.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658